Cleared Traditional

ENDOSPOT (K963043) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963043 · Corin USA · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
46d
Days
Class 2
Risk

K963043 is an FDA 510(k) clearance for the ENDOSPOT. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 46 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 Corin USA devices

Submission Details

510(k) Number K963043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date September 20, 1996
Days to Decision 46 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 130d · This submission: 46d
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 7
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K963043.
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
K121724 · Richard Wolf Medical Instruments Corp. · Sep 2012
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · KARL STORZ Endoscopy-America, Inc. · Sep 2009
STRYKER LED LIGHTSOURCE
K082813 · Stryker Corp. · Dec 2008
WELCH ALLYN HI - LUX ILLUMINATOR
K951647 · Welch Allyn, Inc. · May 1995
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531 · United States Surgical, A Division of Tyco Healthc · May 1994
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · Welch Allyn, Inc. · Aug 1985