Cleared Traditional

K970382 - VS-100 VIDEO SIGMOIDOSCOPE

K970382 is the FDA 510(k) clearance for VS-100 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 73-day FDA review.

K970382 · Welch Allyn, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
73d
Days
Class 2
Risk

K970382 is an FDA 510(k) clearance for the VS-100 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 April 17, 1997 after a review of 73 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 K970382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 17, 1997
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
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 13
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K970382.
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp. · Jun 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577 · Pentax Precision Instrument Corp. · Mar 1996
VIDEO SIGMOIDOSCOPE
K950429 · Welch Allyn, Inc. · Aug 1995
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