Cleared Traditional

K081082 - U-CLIP UNI-FIRE

K081082 is the FDA 510(k) clearance for U-CLIP UNI-FIRE by Medtronic, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K081082 · Medtronic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
21d
Days
Class 2
Risk

K081082 is an FDA 510(k) clearance for the U-CLIP UNI-FIRE, MODEL M65. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Medtronic, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 7, 2008 after a review of 21 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 Medtronic, Inc. devices

Submission Details

510(k) Number K081082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date May 07, 2008
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K081082.
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ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
K081031 · Aesculap, Inc. · May 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · Aesculap, Inc. · Apr 2008
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · United States Surgical, A Division of Tyco Healthc · Nov 2007