510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223377Substantially Equivalent

BIASURGE Advanced Surgical Solution

Rochal Technologies LLC, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223377 is the FDA 510(k) clearance record for BIASURGE Advanced Surgical Solution, cleared for Rochal Technologies, LLC on under FDA product code FRO (Dressing, Wound, Drug). FDA records list one 510(k) clearance for Rochal Technologies, LLC. As of , FDA records show no recalls naming K223377.

Clearance record

Decision date
Received
(146 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Rochal Technologies, LLC 1200 Network Blvd., San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260