Cleared Traditional

K901300 - BIOPSY FORCEPS

K901300 is an FDA 510(k) clearance for BIOPSY FORCEPS, manufactured by Portlyn Corp.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K901300 · Portlyn Corp. · Cardiovascular device
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Jun 1990
Decision
101d
Days
Class 2
Risk

K901300 is an FDA 510(k) clearance for the BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Portlyn Corp. (Moultonboro, US). The FDA issued a Cleared decision on June 29, 1990 after a review of 101 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 Portlyn Corp. devices

FDA 510(k) Submission Details - K901300

510(k) Number K901300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date June 29, 1990
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
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 11
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K901300.
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
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · Dlp, Inc. · Mar 1989
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · Cook, Inc. · Dec 1988
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K882383 · CIVCO Medical Instruments Co., Inc. · Nov 1988