Cleared Traditional

K862562 - PUNCH BIOPSY KIT

K862562 is the FDA 510(k) clearance for PUNCH BIOPSY KIT by Clinipad Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K862562 · Clinipad Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
96d
Days
Class 2
Risk

K862562 is an FDA 510(k) clearance for the PUNCH BIOPSY KIT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Clinipad Corp. (Guilford, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Clinipad Corp. devices

Submission Details

510(k) Number K862562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date October 07, 1986
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 111
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K862562.
WILSON-COOK BIOPSY FORCEPS
K874314 · Wilson-Cook Medical, Inc. · Dec 1987
BARD BIOPTY BIOPSY SYSTEM
K871390 · C.R. Bard, Inc. · Jun 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · Artiberia · May 1985
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · Quinton, Inc. · Aug 1978