Cleared Traditional

AUTO SUTURE TITANIUM HEMOSTATIC CLIP (K853650) - FDA 510(k) Clearance

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

K853650 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Sep 1985
Decision
16d
Days
Class 2
Risk

K853650 is an FDA 510(k) clearance for the AUTO SUTURE TITANIUM HEMOSTATIC CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 16 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K853650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date September 19, 1985
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 56
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K853650.
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · United States Surgical, A Division of Tyco Healthc · Aug 1988
VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER
K864350 · Ethicon, Inc. · Dec 1986
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
K864102 · Ethicon, Inc. · Nov 1986
ETHICON - CHOLANGIOCLIP
K850273 · Ethicon, Inc. · Apr 1985
3M RAPIDSTAT LIGATING CLIP SYS
K842382 · 3M Company · Aug 1984
LIGACLIP METALLIC LIGATING CLIP
K834267 · Ethicon, Inc. · Mar 1984