Cleared Traditional

K790338 - COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER

K790338 is an FDA 510(k) clearance for COLONOSCOPE, manufactured by American Optical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K790338 · American Optical Corp. · Gastroenterology & Urology device
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Apr 1979
Decision
42d
Days
Class 2
Risk

K790338 is an FDA 510(k) clearance for the COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER. 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 April 4, 1979 after a review of 42 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.

FDA 510(k) Submission Details - K790338

510(k) Number K790338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1979
Decision Date April 04, 1979
Days to Decision 42 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
89d faster than avg
Panel avg: 131d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

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 114
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K790338.
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
K810654 · First Industries, Inc. · Mar 1981
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · Pentax Precision Instrument Corp. · Jun 1980
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · American Optical Corp. · Dec 1979
COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
K760452 · American Cystocope Makers, Inc. · Aug 1976
K790338 · COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
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