Cleared Special

K072525 - ZIPKNOT, MODEL 1017-3000 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072525 · Medicinelodge, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
28d
Days
Class 2
Risk

K072525 is an FDA 510(k) clearance for the ZIPKNOT, MODEL 1017-3000. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Medicinelodge, Inc. (Logan, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medicinelodge, Inc. devices

Submission Details

510(k) Number K072525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date October 05, 2007
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 175
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K072525.
InnoClip Clip Applier
K253781 · Taiwan Surgical Corporation · Dec 2025
InnoClip Disposable Clip Applier
K253903 · Taiwan Surgical Corporation · Dec 2025
Disposable Polymer Ligation Clips
K250643 · Hangzhou Kangji Medical Instrument Co., Ltd. · Nov 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · Teleflex Medical · Jul 2025
GEM ZIPCLIP
K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int · Jan 2025
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024