Profile: Apollo Endosurgery Inc specializes in therapeutic flexible endoscopy products. OverStitch™ endoscopic suturing system (ESS) is a device that mimics the way physicians deploy sutures by hand. Full-thickness endoscopic suturing on a flexible platform, delivering surgical standard of care through the flexible endoscope. Single-patient use for reliability and patient safety. Capable of deploying a running stitch as well as interrupted sutures with a single insertion of the endoscope. FlexShears™ endoscopic scissors is for a breakthrough in endoscopic cutting, single-patient use design delivers optimal performance and reliability. Its 360-degree, continuous rotation allows for precise orientation of blades to targeted tissue. Tactile feedback provides sense of control when cutting tissue, suture, mesh or other targeted material.
FDA Registration Number: 3006722112
7 Products/Services (Click for related suppliers)
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| • Electric Biopsy Forceps (FDA Code: KGE / 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. |
| • Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300) |
| • Endoscopic Scissors |
| • Endoscopic Suturing Devices (FDA Code: MFJ / 876.1500) |
| • Endoscopic Tissue Approximation Device (FDA Code: OCW / 876.1500) |
| • Flexible Endoscopic Scissors |
| • Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |