Cleared Traditional

K792179 - AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE

K792179 is the FDA 510(k) clearance for AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE by American Optical Corp.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

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
Combination Product No
PCCP Authorized No
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 66
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K792179.
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · Pentax Precision Instrument Corp. · Apr 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · Pentax Precision Instrument Corp. · Mar 1981
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · Pentax Precision Instrument Corp. · Jun 1980
COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
K790338 · American Optical Corp. · Apr 1979