Cleared Traditional

K820790 - FLEXIBLE PROCTOSIGMOIDOSCOPE

K820790 is the FDA 510(k) clearance for FLEXIBLE PROCTOSIGMOIDOSCOPE by American Optical Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAM) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K820790 · American Optical Corp. · Gastroenterology & Urology device
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Apr 1982
Decision
9d
Days
Class 2
Risk

K820790 is an FDA 510(k) clearance for the FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 9 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 K820790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date April 01, 1982
Days to Decision 9 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
121d faster than avg
Panel avg: 130d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAM Sigmoidoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Sigmoid (descending) Colon
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 - FAM Sigmoidoscope And Accessories, Flexible/rigid

All 14
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K820790.
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · Pentax Precision Instrument Corp. · Jun 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · Pentax Precision Instrument Corp. · Jun 1995
FS-38H, FIBER SIGMOIDOSCOPE
K951573 · Pentax Precision Instrument Corp. · Jun 1995
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K812965 · American Optical Corp. · Nov 1981
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · Pentax Precision Instrument Corp. · Dec 1979
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K792314 · Icl Scientific · Dec 1979