Cleared Traditional

3M PRECISE BRAND INTERNAL SURGICAL STAPLES (K921051) - FDA 510(k) Clearance

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

K921051 · 3M Health Care, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
133d
Days
Class 2
Risk

K921051 is an FDA 510(k) clearance for the 3M PRECISE BRAND INTERNAL SURGICAL STAPLES. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on July 16, 1992 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Health Care, Ltd. devices

Submission Details

510(k) Number K921051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date July 16, 1992
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 108
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K921051.
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
PROXIMATE ABSORBABLE STAPLES
K915693 · Ethicon, Inc. · Mar 1992
AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE
K915489 · United States Surgical, A Division of Tyco Healthc · Jan 1992
AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER
K913802 · United States Surgical, A Division of Tyco Healthc · Oct 1991