Cleared Traditional

PRODEK (K953609) - FDA 510(k) Clearance

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

K953609 · Sutures , Ltd. · General & Plastic Surgery device
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Jan 1996
Decision
182d
Days
Class 2
Risk

K953609 is an FDA 510(k) clearance for the PRODEK. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Sutures , Ltd. (Ruabon, Wrexham, GB). The FDA issued a Cleared decision on January 31, 1996 after a review of 182 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 Sutures , Ltd. devices

Submission Details

510(k) Number K953609 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 02, 1995
Decision Date January 31, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 20
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K953609.
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc. · May 1998
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
USSC POLYPROPLENE SUTURE
K954808 · United States Surgical, A Division of Tyco Healthc · Feb 1996
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437 · Ethicon, Inc. · Jul 1992
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872 · United States Surgical, A Division of Tyco Healthc · Sep 1990