Cleared Traditional

K921051 - 3M PRECISE BRAND INTERNAL SURGICAL STAPLES

K921051 is an FDA 510(k) clearance for 3M PRECISE BRAND INTERNAL SURGICAL STAPLES, manufactured by 3M Health Care, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

FDA 510(k) Submission Details - K921051

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
Combination Product No
PCCP Authorized No
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.

GDW Device Classification - Class 2, Special Controls

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 258
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K921051.
STRYKER STAPLER SYSTEM
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ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992
HEM-O-LOK -- MODIFICATION
K922186 · Linvatec Corp. · 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