Cleared Traditional

K130857 - PRONTOSAN WOUND GEL X

K130857 · B.Braun Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
194d
Days
-
Risk

K130857 is an FDA 510(k) clearance for the PRONTOSAN WOUND GEL X. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 194 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.

FDA 510(k) Submission Details - K130857

510(k) Number K130857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date October 08, 2013
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 686
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K130857 · PRONTOSAN WOUND GEL X
Download PDF FDA Summary B.Braun Medical, Inc.