# Omniguide, Inc.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 14 (2006–2021): 14 510(k) clearances
- Product codes: GEX (14)
- 510(k) review time since 2016: median 73 days, against 88 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 34 (13 its own); citations of its devices by later devices: 15 (13 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Omniguide Communications, Inc.: 5 (https://510kreport.com/company/omniguide-communications)
- Clinicon Corp.: 4 (https://510kreport.com/company/clinicon)
- Kirwan Surgical Products, Inc.: 2 (https://510kreport.com/company/kirwan-surgical-products)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Storz Instrument Co.: 1 (https://510kreport.com/company/storz-instrument)
- Tti Medical: 1 (https://510kreport.com/company/tti-medical)
- Symmetry Medical USA, Inc.: 1 (https://510kreport.com/company/symmetry-medical-usa)
- Surgilase, Inc.: 1 (https://510kreport.com/company/surgilase)

## Firms that cite its devices most
- Bovie Medical Corporation: 1 (https://510kreport.com/company/bovie-medical)
- W and R Investments Dba Laser Engineering: 1 (https://510kreport.com/company/w-and-r-investments-dba-laser-engineering)

## Its most-cited devices
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber (2007), cited by 4
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (2009), cited by 2
- K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray (2008), cited by 2
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), cited by 2
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (2014), cited by 1
- K062423: Omniguide Beampath Laser Beam Delivery System (2006), cited by 1

## Recent decisions
- K203241: OmniGuide BeamPath OTO-U Fiber (Jan 14, 2021)
- K183199: TRIO Handpiece (May 2, 2019)
- K180993: Beacon Advanced CO2 Laser System (Jun 28, 2018)
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (Sep 25, 2014)
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (Nov 20, 2009)
- K093251: Omniguide Beampath Fels 25A CO2 Laser System (Oct 29, 2009)
- K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray (Aug 12, 2008)
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (Jan 2, 2008)

Source page: https://510kreport.com/company/omniguide