# K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Jul 12, 1999 after 82 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912089 (1991). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962116: Galileo Endoscopes, Galileo Electro-Optics Corp. (1996) Summary page 1.
- K981928: Galileo Disposable Endoscopes, Galileo Electro-Optics Corp. (1998) Summary page 1.
- K944079: Imagyn Microlap (TM) Laparoscope, Imagyn Medical, Inc. (1995) Summary page 1.
- K943593: Saratoga Modular Miniature Endoscope System, Ovamed Corp. (1995) Summary page 1.
- K962255: Clarus Murphypen Endoscope (2127-XXX), Clarus Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K080780: Anchorage Scope, Model 000003 (2008), 0 descendants of its own
- K993445: Omnisonic Endoscopic Deflector (1999), 0 descendants of its own

## Indications for use
The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications: Ureteroscopy Bronshoscopy Thoracoscopy NasopharyngoscopySinuscopy General laparoscopy Urology Gynecological

Source page: https://510kreport.com/device/K991377
Methodology: https://510kreport.com/methodology