Cleared Traditional

K971201 - AUTO SUTURE* ILM** KIT

K971201 is the FDA 510(k) clearance for AUTO SUTURE* ILM** KIT by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K971201 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
63d
Days
Class 2
Risk

K971201 is an FDA 510(k) clearance for the AUTO SUTURE* ILM** KIT. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on June 3, 1997 after a review of 63 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K971201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1997
Decision Date June 03, 1997
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 103
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K971201.
IMPLANTABLE CLIP FOR GENERAL SURGERY
K993135 · Applied Medical Resources · Dec 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc · Jan 1999
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc · Jul 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