Cleared Traditional

K981582 - SURGILON

K981582 is an FDA 510(k) clearance for SURGILON, manufactured by Davis & Geck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K981582 · Davis & Geck, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
70d
Days
Class 2
Risk

K981582 is an FDA 510(k) clearance for the SURGILON, DERMALON, & OPHTHALON. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K981582

510(k) Number K981582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date July 13, 1998
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 17
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K981582.
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · Aesculap, Inc. · Mar 1999
NON-ABSORBABLE SURGICAL SUTURES
K930517 · Alcon Laboratories · Dec 1993
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
K930586 · Davis & Geck, Inc. · Dec 1993
VISITEC MICROSURGICAL SUTURE
K922530 · Visitec Co. · Oct 1992