Cleared Traditional

K883723 - FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

K883723 is an FDA 510(k) clearance for FLEXIBLE MYOCARDIAL BIOPSY FORCEPS, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K883723 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
96d
Days
Class 2
Risk

K883723 is an FDA 510(k) clearance for the FLEXIBLE MYOCARDIAL BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4075 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K883723

510(k) Number K883723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date December 05, 1988
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWZ Device Classification - Class 2, Special Controls

Product Code DWZ Device, Biopsy, Endomyocardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4075
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWZ Device, Biopsy, Endomyocardial

All 15
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K883723.
CORDIS BIPAL BIOPSY FORCEPS
K914567 · Cordis Corp. · Dec 1991
BIOPSY FORCEPS
K895098 · Annex Medical, Inc. · Oct 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · Dlp, Inc. · Mar 1989
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K882383 · CIVCO Medical Instruments Co., Inc. · Nov 1988
CORDIS BIOPSY FORCEPS
K810849 · Cordis Corp. · Apr 1981