Cleared Traditional

K021808 - WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER

K021808 is an FDA 510(k) clearance for WECK HEM-O-LOK AUTOMATIC LIGATING CLIP ..., manufactured by Weck. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K021808 · Weck · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
72d
Days
Class 2
Risk

K021808 is an FDA 510(k) clearance for the WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Weck (Durham, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 72 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 Weck devices

FDA 510(k) Submission Details - K021808

510(k) Number K021808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2002
Decision Date August 14, 2002
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 125
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K021808.
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc. · Dec 2003
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp. · Oct 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · Advanced Surgical Products, Inc. · Jul 2003
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · American Medical Systems, Inc. · Sep 2001
BIOPSY SITE MARKER
K011402 · Senorx, Inc. · Jul 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp. · May 2001