Cleared Traditional

K971373 - VISTA SINGLE CHIP VIDEO CAMERA

K971373 is an FDA 510(k) clearance for VISTA SINGLE CHIP VIDEO CAMERA, manufactured by Vista Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K971373 · Vista Medical Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
36d
Days
Class 2
Risk

K971373 is an FDA 510(k) clearance for the VISTA SINGLE CHIP VIDEO CAMERA. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Vista Medical Technologies, Inc. (Westborough, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 36 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 Vista Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K971373

510(k) Number K971373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date May 20, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 131d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 73
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K971373.
KARL STORZ DIRECT COUPLED CAMERA HEAD
K973252 · Karl Storz Imaging, Inc. · Nov 1997
S-357 VIDEO IMAGING SYSTEM
K972540 · Sopro · Sep 1997
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K971416 · Olympus America, Inc. · Jul 1997
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
K964173 · Richard Wolf Medical Instruments Corp. · Dec 1996
S-57 VIDEO IMAGING SYSTEM
K962024 · Del Medical Systems Corp. · Jul 1996
EVIS 140 SYSTEM
K954451 · Olympus America, Inc. · Mar 1996