510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231937Substantially Equivalent

Foundation Dermal Regeneration Scaffold (DRS) Solo

Bionova Medical, Inc., Germantown TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231937 is the FDA 510(k) clearance record for Foundation Dermal Regeneration Scaffold (DRS) Solo, cleared for Bionova Medical, Inc. on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 6 510(k) clearances for Bionova Medical, Inc., from to . As of , FDA records show no recalls naming K231937.

Clearance record

Decision date
Received
(136 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Bionova Medical, Inc. 3012 Centre Oak Way, Germantown TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGN

Trailing 12 months
16 clearances under product code KGN in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code KGN, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20262
March 20261
April 20260
May 20261
June 20265
July 20261
August 20261
September 20261
October 20260