Cleared Traditional

K950429 - VIDEO SIGMOIDOSCOPE

K950429 is the FDA 510(k) clearance for VIDEO 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 180-day FDA review.

K950429 · Welch Allyn, Inc. · Gastroenterology & Urology device
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Aug 1995
Decision
180d
Days
Class 2
Risk

K950429 is an FDA 510(k) clearance for the VIDEO SIGMOIDOSCOPE. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on August 1, 1995 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Welch Allyn, Inc. devices

Submission Details

510(k) Number K950429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1995
Decision Date August 01, 1995
Days to Decision 180 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 130d · This submission: 180d
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 K950429.
VS-100 VIDEO SIGMOIDOSCOPE
K970382 · Welch Allyn, Inc. · Apr 1997
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp. · Jun 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577 · Pentax Precision Instrument Corp. · Mar 1996
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