Cleared Traditional

BIASURGE Advanced Surgical Solution (K223377) - FDA 510(k) Clearance

K223377 · Rochal Technologies, LLC · General & Plastic Surgery device
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Mar 2023
Decision
146d
Days
-
Risk

K223377 is an FDA 510(k) clearance for the BIASURGE Advanced Surgical Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Rochal Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on March 30, 2023 after a review of 146 days - within the typical 510(k) review window.

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 Rochal Technologies, LLC devices

Submission Details

510(k) Number K223377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2022
Decision Date March 30, 2023
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
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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