Cleared Traditional

K962016 - MEDLINE TITANIUM HEMOCLIPS

K962016 is the FDA 510(k) clearance for MEDLINE TITANIUM HEMOCLIPS by Medline Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K962016 · Medline Industries, Inc. · General & Plastic Surgery device
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Jul 1996
Decision
62d
Days
Class 2
Risk

K962016 is an FDA 510(k) clearance for the MEDLINE TITANIUM HEMOCLIPS. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 24, 1996 after a review of 62 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K962016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date July 24, 1996
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
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 K962016.
AUTO SUTURE* ILM** KIT
K971201 · United States Surgical, A Division of Tyco Healthc · Jun 1997
APPLIED MEDICAL CLIP APPLIER
K964470 · Applied Medical Resources · Jan 1997
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · United States Surgical, A Division of Tyco Healthc · Sep 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