# K993445: Omnisonic Endoscopic Deflector

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Dec 6, 1999 after 55 days
- Product code: GCM (Endoscope, Rigid)
- 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: 3 generations back to K912089 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler, Omnisonics Medical Technologies (1999) Summary page 4.
- K990411: MVM 7.5 French Flexible Hysteroscope, Karl Storz Endoscopy (1999) Summary page 4.
- K974683: Naviport Deflectable Tip Guiding Catheter, Cardima, Inc. (1999) Summary page 4.
- (no number) Karl Storz Laser Application Instrument: named in the summary without a submission number

## Indications for use
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of small diameter malleable instruments, catheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals. The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications: Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy

Source page: https://510kreport.com/device/K993445
Methodology: https://510kreport.com/methodology