Annex Medical, Inc.
Contact: Eugene Karels - VP & GM
Web: http://www.annexmedical.com
E-Mail:
Address: 6018 Blue Circle Dr., Minnetonka, Minnesota 55343, USA
Phone: +1-(952)-942-7576 | Fax: +1-(952)-942-7590 | Map/Directions >>
Profile: Annex Medical, Inc. provides design and manufacturing resources to medical product companies. Our single use accessory devices for endoscopes include retrieval and biopsy devices. We offer finished products on an OEM basis to companies marketing to end users. Our products are designed and manufactured to meet the quality and safety standards. Our quality system is ISO 13485 registered. Our focus is on specialty devices for use with small diameter endoscopes. Our devices are designed to allow easy passage through a flexible endoscope and smooth actuation in tortuous paths. All devices are made to order to accommodate requirements for sheath diameter, working length and tip design. Our endoscope accessories are available as sterile or non-sterile packages. Our standard handle is of a 3 ring design, which allows for precise, single hand operation using either the right or left hand. Our endoscope accessory devices are designed for use in ureteroscopy and laparoscopic cholecystectomy procedures. Our baskets and grasping forceps grasp and remove objects such as urinary or biliary calculi. Our biopsy brushes obtain tissue samples for biopsy. These devices are all designed to operate through the working channel of flexible, small diameter and semi-rigid endoscopes.
The company was founded in 1988 and is ISO 9001, CE certified.
FDA Registration Number: 2183873
14 Products/Services (Click for related suppliers)
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| • Biopsy Brushes |
| • Endomyocardial Biopsy Device (FDA Code: DWZ / 870.4075) An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart. |
| • Endoscopic Cytology Brush (FDA Code: FDX / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Endoscopic Laser Accessories |
| • Endoscopic Retrieval Devices |
| • Endoscopic Suturing Devices (FDA Code: MFJ / 876.1500) |
| • Flexible Snare (FDA Code: FDI / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. |
| • Flexible Stone Dislodger (FDA Code: FGO / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger. |
| • Grasping Forceps |
| • Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680) |
| • Non Retracting Grasping Forceps |
| • Non-Electric Biopsy Forceps (FDA Code: FCL / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Ureteroscopy, Urethral Access Sheaths |
| • Urethral Access Sheaths |
