Cleared Traditional

Suprasorb A + Ag “R” (K183208) - FDA 510(k) Clearance

K183208 · Speciality Fibres and Materials, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
269d
Days
-
Risk

K183208 is an FDA 510(k) clearance for the Suprasorb A + Ag “R”. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Speciality Fibres and Materials, Ltd. (Coventry, GB). The FDA issued a Cleared decision on August 15, 2019 after a review of 269 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Speciality Fibres and Materials, Ltd. devices

Submission Details

510(k) Number K183208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date August 15, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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