Cleared Traditional

K770291 - SIGMOIDOSCOPE

K770291 is the FDA 510(k) clearance for SIGMOIDOSCOPE by Welch Allyn, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAM) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770291 · Welch Allyn, Inc. · Gastroenterology & Urology device
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Feb 1977
Decision
4d
Days
Class 2
Risk

K770291 is an FDA 510(k) clearance for the SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Walker, US). The FDA issued a Cleared decision on February 18, 1977 after a review of 4 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K770291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1977
Decision Date February 18, 1977
Days to Decision 4 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
126d faster than avg
Panel avg: 130d · This submission: 4d
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 K770291.
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · Pentax Precision Instrument Corp. · Dec 1979
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K792314 · Icl Scientific · Dec 1979
SIGMOIDOSCOPE TIPLESS
K790610 · Welch Allyn, Inc. · Apr 1979
SIGMOIDOSCOPE/ DISPOSABLE
K761180 · Smithkline Diagnostics, Inc. · Jan 1977
BRIDGE, SHORT DEFLECTING
K760173 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976