Cleared Traditional

K792179 - AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K792179 · American Optical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1979
Decision
38d
Days
Class 2
Risk

K792179 is an FDA 510(k) clearance for the AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Optical Corp. devices

Submission Details

510(k) Number K792179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1979
Decision Date December 06, 1979
Days to Decision 38 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 130d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 110
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K792179.
Disposable Distal End Tape Hood
K252457 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Jan 2026
ROBOPERA (ER-R-002)
K244029 · Endorobotics Co., Ltd. · Sep 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · Fujifilm Corporation · May 2025
Colonovideoscope (CF-EZ1500DL)
K250432 · Olympus Medical Systems Corporation · May 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · Pentax of America, Inc. · Jan 2025
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K242325 · Actuated Medical, Inc. · Oct 2024