Cleared Traditional

K032238 - TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER

K032238 is an FDA 510(k) clearance for TWISTER SUPERELASTIC LIGATING CLIP AND ..., manufactured by Neurosel (Medical) Limited. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K032238 · Neurosel (Medical) Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
50d
Days
Class 2
Risk

K032238 is an FDA 510(k) clearance for the TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Neurosel (Medical) Limited (Andover, Hampshire, GB). The FDA issued a Cleared decision on September 9, 2003 after a review of 50 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 Neurosel (Medical) Limited devices

FDA 510(k) Submission Details - K032238

510(k) Number K032238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date September 09, 2003
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 124
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K032238.
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344 · Ethicon Endo-Surgery, Inc. · Mar 2005
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