Cleared Traditional

K923161 - BRAIDED POLYESTER SUTURE MATERIAL (FDA 510(k) Clearance)

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

K923161 · Mitek Surgical Products, Inc. · General & Plastic Surgery device
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Dec 1992
Decision
184d
Days
Class 2
Risk

K923161 is an FDA 510(k) clearance for the BRAIDED POLYESTER SUTURE MATERIAL. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on December 30, 1992 after a review of 184 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K923161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date December 30, 1992
Days to Decision 184 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
70d slower than avg
Panel avg: 114d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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.