Cleared Traditional

K984550 - PRE-THREADED ENDOBUTTON

K984550 is the FDA 510(k) clearance for PRE-THREADED ENDOBUTTON by Smith & Nephew, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K984550 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
69d
Days
Class 2
Risk

K984550 is an FDA 510(k) clearance for the PRE-THREADED ENDOBUTTON. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 69 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, Inc. devices

Submission Details

510(k) Number K984550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1998
Decision Date March 01, 1999
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K984550.
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc. · Sep 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc. · May 2001
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · United States Surgical, A Division of Tyco Healthc · Apr 1999
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