Cleared Traditional

K981645 - TITANIUM HEMOSTATIC CLIP

K981645 is an FDA 510(k) clearance for TITANIUM HEMOSTATIC CLIP, manufactured by Vitalitec Int'L., Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K981645 · Vitalitec Int'L., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
158d
Days
Class 2
Risk

K981645 is an FDA 510(k) clearance for the TITANIUM HEMOSTATIC CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Vitalitec Int'L., Inc. (Plymouth, US). The FDA issued a Cleared decision on October 13, 1998 after a review of 158 days - an extended review 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: 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 Vitalitec Int'L., Inc. devices

FDA 510(k) Submission Details - K981645

510(k) Number K981645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date October 13, 1998
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
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 122
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K981645.
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc · Jan 1999
HEM-O-LOK MODEL NUMBERS 523900, 523970
K982941 · Weck Closure Systems · Nov 1998
HEM-O-LOCK, MODEL 523935
K982944 · Weck Closure Systems · Nov 1998
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
K982313 · Weck Closure Systems · Aug 1998
INFLUENCE CLIP SYSTEM
K981631 · Influence, Inc. · Jul 1998
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K981239 · Deroyal Surgical · May 1998