Cleared Traditional

K864350 - VICRYL* POLYGLACTIN 730 ABSORBABLE STAP...

K864350 is the FDA 510(k) clearance for VICRYL* POLYGLACTIN 730 ABSORBABLE STAP... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K864350 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
44d
Days
Class 2
Risk

K864350 is an FDA 510(k) clearance for the VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 18, 1986 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 K864350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date December 18, 1986
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K864350.
HEM-O-LOK(TM)
K902108 · Edward Weck, Inc. · Aug 1990
AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP*
K900122 · United States Surgical, A Division of Tyco Healthc · Mar 1990
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · United States Surgical, A Division of Tyco Healthc · Aug 1988
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
K864102 · Ethicon, Inc. · Nov 1986
TITANIUM HEMOSTATIC CLIPS
K861922 · Pilling Co. · Jun 1986
AUTO SUTURE TITANIUM HEMOSTATIC CLIP
K853650 · United States Surgical, A Division of Tyco Healthc · Sep 1985