Cleared Traditional

K964109 - MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP

K964109 is an FDA 510(k) clearance for MICROSURGE LAPAROSCOPIC PERMACLIP CARTR..., manufactured by Microsurge, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K964109 · Microsurge, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
43d
Days
Class 2
Risk

K964109 is an FDA 510(k) clearance for the MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Microsurge, Inc. (Needham, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 43 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 Microsurge, Inc. devices

FDA 510(k) Submission Details - K964109

510(k) Number K964109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date November 27, 1996
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 123
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K964109.
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc · Jul 1997
AUTO SUTURE* ILM** KIT
K971201 · United States Surgical, A Division of Tyco Healthc · Jun 1997
APPLIED MEDICAL CLIP APPLIER
K964470 · Applied Medical Resources · Jan 1997
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · United States Surgical, A Division of Tyco Healthc · Sep 1996
MEDLINE TITANIUM HEMOCLIPS
K962016 · Medline Industries, Inc. · Jul 1996
TITANIUM HEMOSTATIC CLIP
K953258 · Intramed Laboratories, Inc. · Jan 1996