Cleared Special

K100242 - AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

K100242 is an FDA 510(k) clearance for AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER, manufactured by Surgical Devices, A Division of Tyco Healthcare. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 21-day FDA review.

K100242 · Surgical Devices, A Division of Tyco Healthcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
21d
Days
Class 2
Risk

K100242 is an FDA 510(k) clearance for the AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Surgical Devices, A Division of Tyco Healthcare (North Haven, US). The FDA issued a Cleared decision on February 17, 2010 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. 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 Surgical Devices, A Division of Tyco Healthcare devices

FDA 510(k) Submission Details - K100242

510(k) Number K100242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date February 17, 2010
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 105
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K100242.
ENDOSCOPIC CLIP SYSTEM
K102081 · Aesculap, Inc. · Aug 2010
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
K093679 · AtriCure, Inc. · Jun 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
K091987 · LeMaitre Vascular, Inc. · Apr 2010
U-CLIP UNI-FIRE, MODEL M65
K081082 · Medtronic, Inc. · May 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
K081031 · Aesculap, Inc. · May 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · Aesculap, Inc. · Apr 2008