(FDA Code:
NAJ /
870.33)
Advanced Bionics Corporation,
Boston Scientific Corporation,
Biosphere Medical, Inc.,
more...
(FDA Code:
HFC /
884.105)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.
Classification. Class II (performance standards).
Cooper Surgical, Inc.,
Integrity Medical Systems, Inc.,
Milex Products, Inc.,
more...
B&H Surgical,
Sklar Instruments,
Vienex USA Inc.,
more...
Select Medical Systems, Inc.,
OBJ Products
Endocervical Specula is the instrument that facilitates accurate examination of the endocervical canal for complete patient care. This is fully autoclavable rose coated instruments deliver lasting performance and durability. It includes narrow or standard blades with ratchet or setscrew lock mechanism.
B&H Surgical,
Sklar Instruments,
Fertility Technology Resources, Inc.,
more...
U.S.E Surgical Instruments,
Dealmed Medical Supplies,
Advanced Medical Innovations, Inc.,
more...
(FDA Code:
HFF /
884.106)
Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).
Classification. Class II. The special controls for this device are:
Cooper Surgical, Inc.,
Milex Products, Inc.,
Cook Urological,
more...
Hollow silastic band is placed around the upper part of the stomach, limiting the amount of food a person can eat. It can be adjusted after surgery by injecting or removing saline from the band with a needle.
B&H Surgical,
Howard Medical Company,
Sklar Instruments,
more...
Medgyn Products Inc,
Vienex USA Inc.,
The Medtech Group, Inc.
(FDA Code:
HFE /
884.11)
Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).
Classification. Class II. The special controls for this device are:
Cooper Surgical, Inc.,
Cook Urological,
Berkeley Medevices, Inc.,
more...
Female intrauterine device is a small plastic device that is inserted into the uterus. Its contraceptive action begins as soon as the device is placed in the uterus and stops as soon as it is removed. It is used to prevent pregnancy.
Accolade Surgical Products,
Sklar Instruments
Endometrial Curettes are suction type curettes used to draw tissues for histological assessments. The curette end is single port or multiport. The elongated multiports are suitable for larger area tissue draws. They have a suction plunger to create a constant vacuum. Endocervical curettes are used to take tissue samples from the cervix.
Accolade Surgical Products,
Sklar Instruments,
Berkeley Medevices, Inc.,
more...
B&H Surgical,
Accolade Surgical Products,
Select Medical Systems, Inc.,
more...
(FDA Code:
OKZ /
884.1175)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.
Classification. Class II (performance standards).
Berkeley Medevices, Inc.,
Gyn Disposables, Inc.,
G.P.S. Srl
(FDA Code:
HHK /
884.1175)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.
Classification. Class II (performance standards).
B&H Surgical,
Accolade Surgical Products,
Cooper Surgical, Inc.,
more...
(FDA Code:
MNB)
Laserscope,
Advanced Bionics Corporation,
Cooper Surgical, Inc.,
more...
(FDA Code:
HIM /
884.41)
Identification. An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is designed to coagulate fallopian tube tissue with a probe heated by low-voltage energy. This generic type of device may include the following accessories: electrical generators, probes, and electrical cables.
Classification. Class II. The special controls for this device are:
Elmed Inc.,
George Tiemann & Co.,
Conmed Corporation,
more...
MedoGen, Inc.,
Luxtec,
General Scientific Corporation,
more...
ACI Medical, LLC.,
Bryan Corporation,
Boston Scientific Corporation,
more...
ISPG,
Ranfac Corp.,
Popper & Sons Inc,
more...
R-Group International,
Spectra Medical Devices, Inc.,
PMT Corporation,
more...
R-Group International,
Bard Electrophysiology,
Spectra Medical Devices, Inc.,
more...
(FDA Code:
HDK /
884.452)
Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:
Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 884.9.
Cooper Surgical, Inc.,
Vyaire Medical, Inc.,
Luxtec,
more...
Thermo Fisher Scientific Inc
Miltex, Inc.,
Medinvents
(FDA Code:
HDN /
884.425)
Identification. An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.
Classification. Class III (premarket approval).
Cooper Surgical, Inc.,
R Medical Supply, Inc,
Combined Instruments (Pvt.), Ltd.,
more...
(FDA Code:
HER /
884.452)
Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:
Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 884.9.
Vyaire Medical, Inc.,
Luxtec,
Teleflex Medical,
more...
(FDA Code:
HFM /
884.272)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.
Classification. Class II (performance standards).
Parker Hannifin Corporation.,
Bio-Feedback Systems, Inc.,
Invivo,
more...
Smiths Medical ASD, Inc,
Medesign Gmbh
(FDA Code:
LHD)
Inverness Medical Innovations, Inc.,
Zetek, Inc.,
Microlife USA, Inc.,
more...
Zetek, Inc.,
Healthwatchsystems, Inc.,
JDI Electronics Factory
Jant Pharmacal Corp.,
ACON Laboratories, Inc.,
Quidel Corporation,
more...
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.,
Irvine Scientific,
Fertility Technology Resources, Inc.,
more...
Cooper Surgical, Inc.,
Integrity Medical Systems, Inc.,
Milex Products, Inc.,
more...
B&H Surgical,
Accolade Surgical Products,
Cooper Surgical, Inc.,
more...
Cooper Surgical, Inc.
Cooper Surgical, Inc.,
Biocell Laboratories, Inc.,
Bioresource Technology, Inc.,
more...
Cooper Surgical, Inc.
Cooper Surgical, Inc.,
Thermo Fisher Scientific Inc,
Pochemco, Inc.,
more...
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.
Cooper Surgical, Inc.,
Irvine Scientific,
Fertility Technology Resources, Inc.
Cooper Surgical, Inc.