Cleared Traditional

K915693 - PROXIMATE ABSORBABLE STAPLES

K915693 is the FDA 510(k) clearance for PROXIMATE ABSORBABLE STAPLES by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K915693 · Ethicon, Inc. · General & Plastic Surgery device
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Mar 1992
Decision
87d
Days
Class 2
Risk

K915693 is an FDA 510(k) clearance for the PROXIMATE ABSORBABLE STAPLES. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 87 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 Ethicon, Inc. devices

Submission Details

510(k) Number K915693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date March 19, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K915693.
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992
HEM-O-LOK -- MODIFICATION
K922186 · Linvatec Corp. · Aug 1992
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
K921051 · 3M Health Care, Ltd. · Jul 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
AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER
K913832 · United States Surgical, A Division of Tyco Healthc · Oct 1991