Cleared Traditional

K865038 - SURGISTEEL

K865038 is an FDA 510(k) clearance for SURGISTEEL, manufactured by Sutures , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K865038 · Sutures , Ltd. · General & Plastic Surgery device
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Jun 1987
Decision
188d
Days
Class 2
Risk

K865038 is an FDA 510(k) clearance for the SURGISTEEL. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Sutures , Ltd. (Ruabon, Wrexham, GB). The FDA issued a Cleared decision on June 30, 1987 after a review of 188 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - 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

FDA 510(k) Submission Details - K865038

510(k) Number K865038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1986
Decision Date June 30, 1987
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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.