Cleared Traditional

BIOPSY FORCEPS (K895098) - FDA 510(k) Clearance

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

K895098 · Annex Medical, Inc. · Cardiovascular device
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Oct 1989
Decision
76d
Days
Class 2
Risk

K895098 is an FDA 510(k) clearance for the BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 76 days - a notably fast clearance cycle.

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: 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 Annex Medical, Inc. devices

Submission Details

510(k) Number K895098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date October 30, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K895098.
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289 · Cordis Corp. · Mar 1992
CORDIS BIPAL BIOPSY FORCEPS
K914567 · Cordis Corp. · Dec 1991
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · Cook, Inc. · Dec 1988
CORDIS BIOPSY FORCEPS
K810849 · Cordis Corp. · Apr 1981