Cleared Traditional

WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES (K954435) - FDA 510(k) Clearance

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

K954435 · Wilo Medizintechnik Lothar Wilberg GmbH · General & Plastic Surgery device
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Oct 1995
Decision
31d
Days
Class 2
Risk

K954435 is an FDA 510(k) clearance for the WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Wilo Medizintechnik Lothar Wilberg GmbH (Washington, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 31 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 Wilo Medizintechnik Lothar Wilberg GmbH devices

Submission Details

510(k) Number K954435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1995
Decision Date October 23, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
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 57
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K954435.
AUTO SUTURE* ILM** KIT
K971201 · United States Surgical, A Division of Tyco Healthc · Jun 1997
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · United States Surgical, A Division of Tyco Healthc · Sep 1996
MEDLINE TITANIUM HEMOCLIPS
K962016 · Medline Industries, Inc. · Jul 1996
IMPLANTABLE CLIP
K950540 · United States Surgical, A Division of Tyco Healthc · Apr 1995
IMPLANTABLE CLIP APPLIER
K934087 · United States Surgical, A Division of Tyco Healthc · Dec 1993
IMPLANTABLE CLIP
K933887 · United States Surgical, A Division of Tyco Healthc · Nov 1993