Cleared Traditional

K970416 - ACUFEX DOUBLE ARMED SUTURE NEEDLE

K970416 is the FDA 510(k) clearance for ACUFEX DOUBLE ARMED SUTURE NEEDLE by Smith & Nephew Endoscopy, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K970416 · Smith & Nephew Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
76d
Days
Class 2
Risk

K970416 is an FDA 510(k) clearance for the ACUFEX DOUBLE ARMED SUTURE NEEDLE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Mansfield, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Smith & Nephew Endoscopy, Inc. devices

Submission Details

510(k) Number K970416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date April 21, 1997
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K970416.
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE
K990088 · Aesculap, Inc. · Feb 1999
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · United States Surgical, A Division of Tyco Healthc · Apr 1998
ENDOBUTTON CONTINUOUS LOOP
K980155 · Smith & Nephew, Inc. · Apr 1998
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ACUFEX ENDOBUTTON TAPE
K952535 · Acufex Microsurgical, Inc. · Feb 1996
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993