Cleared Traditional

K934531 - AUTO SUTURE DISPOSABLE LIGHT CABLE

K934531 is the FDA 510(k) clearance for AUTO SUTURE DISPOSABLE LIGHT CABLE by United States Surgical, A Division of Tyco Healthc. It is a Class 2 Gastroenterology & Urology device (product code FCW) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K934531 · United States Surgical, A Division of Tyco Healthc · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
240d
Days
Class 2
Risk

K934531 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE LIGHT CABLE. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 18, 1994 after a review of 240 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K934531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date May 18, 1994
Days to Decision 240 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
110d slower than avg
Panel avg: 130d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FCW Light Source, Fiberoptic, Routine

All 12
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K934531.
STRYKER LED LIGHTSOURCE
K082813 · Stryker Corp. · Dec 2008
ENDOSPOT
K963043 · Corin USA · Sep 1996
WELCH ALLYN HI - LUX ILLUMINATOR
K951647 · Welch Allyn, Inc. · May 1995
STORZ S6000 LIGHT SOURCE
K905376 · Storz Instrument Co. · Jan 1991
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · Welch Allyn, Inc. · Aug 1985
PEDIATRIC ILLUMINATING URETERAL
K832807 · Van-Tec, Inc. · Oct 1983