Cleared Traditional

SURGISORB (K984374) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984374 · Samyang Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
179d
Days
Class 2
Risk

K984374 is an FDA 510(k) clearance for the SURGISORB. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Samyang Corp. (Pleasant Hill, US). The FDA issued a Cleared decision on June 4, 1999 after a review of 179 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Samyang Corp. devices

Submission Details

510(k) Number K984374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date June 04, 1999
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 62
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K984374.
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc. · Aug 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · Aesculap, Inc. · Jun 2001
MONOFILAMENT BIOSYN SUTURE
K000037 · United States Surgical, A Division of Tyco Healthc · Mar 2000
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · United States Surgical, A Division of Tyco Healthc · Apr 1999
POLYSORB SUTURE
K981935 · United States Surgical, A Division of Tyco Healthc · Jun 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · Aesculap, Inc. · May 1998