Cleared Traditional

K971734 - VG 200 VIDEO GASTROSCOPE

K971734 is the FDA 510(k) clearance for VG 200 VIDEO GASTROSCOPE by Welch Allyn, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K971734 · Welch Allyn, Inc. · Gastroenterology & Urology device
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Jul 1997
Decision
78d
Days
Class 2
Risk

K971734 is an FDA 510(k) clearance for the VG 200 VIDEO GASTROSCOPE. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 78 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 K971734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date July 29, 1997
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. 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 - FDS Gastroscope And Accessories, Flexible/rigid

All 56
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K971734.
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K060907 · KARL STORZ Endoscopy-America, Inc. · Nov 2006
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · Pentax Precision Instrument Corp. · Feb 2002
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
K984358 · Olympus America, Inc. · Sep 1999
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
K971660 · Olympus America, Inc. · Jul 1997
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · Olympus America, Inc. · Feb 1997
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K962897 · Pentax Precision Instrument Corp. · Oct 1996