Cleared Traditional

K920510 - URESIL LOCKING GENERAL PURPOSE DRAINAGE...

K920510 is an FDA 510(k) clearance for URESIL LOCKING GENERAL PURPOSE DRAINAGE..., manufactured by Uresil Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K920510 · Uresil Corp. · General & Plastic Surgery device
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Sep 1992
Decision
225d
Days
Class 2
Risk

K920510 is an FDA 510(k) clearance for the URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 225 days - an extended review 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: 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 Uresil Corp. devices

FDA 510(k) Submission Details - K920510

510(k) Number K920510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1992
Decision Date September 14, 1992
Days to Decision 225 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 115d · This submission: 225d
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 K920510.
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
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc · Jan 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc · Jan 1991
NONABSORBABLE NYLON SURGICAL SUTURE*
K900531 · United States Surgical, A Division of Tyco Healthc · Jul 1990