Cleared Traditional

PRECISE BARND PI DISPOSABLE SURGICAL STAPLES (K911252) - FDA 510(k) Clearance

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

K911252 · 3M Medical Products Group · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
126d
Days
Class 2
Risk

K911252 is an FDA 510(k) clearance for the PRECISE BARND PI DISPOSABLE SURGICAL STAPLES. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by 3M Medical Products Group (St Paul, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 126 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 Medical Products Group devices

Submission Details

510(k) Number K911252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1991
Decision Date July 25, 1991
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 K911252.
AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES
K914130 · United States Surgical, A Division of Tyco Healthc · Oct 1991
AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER
K913211 · United States Surgical, A Division of Tyco Healthc · Sep 1991
IMPLANTABLE METAL STAPLES
K913139 · Ethicon, Inc. · Sep 1991
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
K910192 · United States Surgical, A Division of Tyco Healthc · Feb 1991
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
K905106 · United States Surgical, A Division of Tyco Healthc · Jan 1991
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
K900129 · United States Surgical, A Division of Tyco Healthc · Feb 1990