Cleared Traditional

K911252 - PRECISE BARND PI DISPOSABLE SURGICAL ST...

K911252 is an FDA 510(k) clearance for PRECISE BARND PI DISPOSABLE SURGICAL ST..., manufactured by 3M Medical Products Group. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K911252 · 3M Medical Products Group · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K911252

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.

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 160
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K911252.
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
DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING
K913411 · Davis & Geck, 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