Cleared Traditional

K941972 - HEMO-O-LOK

K941972 is an FDA 510(k) clearance for HEMO-O-LOK, manufactured by King & Spalding. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K941972 · King & Spalding · General & Plastic Surgery device
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Jun 1994
Decision
68d
Days
Class 2
Risk

K941972 is an FDA 510(k) clearance for the HEMO-O-LOK. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by King & Spalding (Washington, US). The FDA issued a Cleared decision on June 29, 1994 after a review of 68 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 King & Spalding devices

FDA 510(k) Submission Details - K941972

510(k) Number K941972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date June 29, 1994
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
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 142
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K941972.
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