Cleared Traditional

SURGICAL STAPLE MARKER DEVICE (MODIFY) (K963015) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963015 · Biopsys Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
74d
Days
Class 2
Risk

K963015 is an FDA 510(k) clearance for the SURGICAL STAPLE MARKER DEVICE (MODIFY). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Biopsys Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery 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 Biopsys Medical, Inc. devices

Submission Details

510(k) Number K963015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1996
Decision Date October 07, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 107
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K963015.
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995
SURGICAL STAPLE
K942606 · United States Surgical, A Division of Tyco Healthc · Aug 1994
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992