Cleared Traditional

K043115 - LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)

K043115 is an FDA 510(k) clearance for LAPAROSCOPIC COMPRESSION ANASTOMOSIS CL..., manufactured by Niti Medical Technologies , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K043115 · Niti Medical Technologies , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
21d
Days
Class 2
Risk

K043115 is an FDA 510(k) clearance for the LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC). Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Niti Medical Technologies , Ltd. (Netanya, IL). The FDA issued a Cleared decision on December 1, 2004 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.

FDA 510(k) Submission Details - K043115

510(k) Number K043115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2004
Decision Date December 01, 2004
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.

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 176
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K043115.
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories · Jun 2005
COMPRESSION ANASTOMOSIS RING (CAR)
K050356 · Niti Medical Technologies , Ltd. · May 2005
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
K050344 · Ethicon Endo-Surgery, Inc. · Mar 2005
COMPRESSION ANASTOMOSIS CLIP (CAC)
K041751 · Niti Medical Technologies , Ltd. · Sep 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K033324 · Niti Medical Technologies , Ltd. · May 2004
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K040602 · Design Standards Corp. · May 2004
K043115 · LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
Download PDF FDA Summary Niti Medical Technolo…