Cleared Traditional

K945231 - SELF-LATCHING CLIP

K945231 is an FDA 510(k) clearance for SELF-LATCHING CLIP, manufactured by Surgical System, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K945231 · Surgical System, Inc. · General & Plastic Surgery device
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Jan 1995
Decision
92d
Days
Class 2
Risk

K945231 is an FDA 510(k) clearance for the SELF-LATCHING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Surgical System, Inc. (Succasunna, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 92 days - within the typical 510(k) review window.

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: 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 Surgical System, Inc. devices

FDA 510(k) Submission Details - K945231

510(k) Number K945231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date January 27, 1995
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

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 151
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K945231.
TITANIUM HEMOSTATIC CLIP
K953258 · Intramed Laboratories, Inc. · Jan 1996
DAVIS & GECK LIGATING CLIP REMOVER
K953908 · Davis & Geck, Inc. · Nov 1995
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
LAPRA-TY* SUTURE CLIP
K931492 · Ethicon, Inc. · Aug 1993