Cleared Traditional

K943216 - SURGIDEK

K943216 is an FDA 510(k) clearance for SURGIDEK, manufactured by Sutures , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K943216 · Sutures , Ltd. · General & Plastic Surgery device
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Dec 1994
Decision
153d
Days
Class 2
Risk

K943216 is an FDA 510(k) clearance for the SURGIDEK. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Sutures , Ltd. (Ruabon, Wrexham, GB). The FDA issued a Cleared decision on December 5, 1994 after a review of 153 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.

FDA 510(k) Submission Details - K943216

510(k) Number K943216 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 05, 1994
Decision Date December 05, 1994
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
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 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K943216.
SURGILON, DERMALON, & OPHTHALON
K981582 · Davis & Geck, Inc. · Jul 1998
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
K981322 · Genzyme Surgical Product (Genzyme Biosurgery) · Jul 1998
NYLON NOABSORBABLE SURGICAL SUTURES USP
K960327 · R. K. Medical L. L. C. · Mar 1996
SURGIDEK S
K943222 · Sutures , Ltd. · Dec 1994
SURGIDEK B
K943223 · Sutures , Ltd. · Dec 1994
SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE
K931914 · Surgimetrics International, Ltd. · Oct 1994
K943216 · SURGIDEK
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