510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933817Substantially Equivalent

Royl-Derm Wound Hydrogel Sterile Unit Dose

Renaissance Medical, Inc., Dana Point CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933817 is the FDA 510(k) clearance record for ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE, cleared for Renaissance Medical, Inc. on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 4 510(k) clearances for Renaissance Medical, Inc., from to . As of , FDA records show no recalls naming K933817.

Clearance record

Decision date
Received
(159 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Renaissance Medical, Inc. 24666 Morningstar Ln., Dana Point CA
510(k) summary
Statement
Third party review
No

Clearances, product code MGQ

Trailing 12 months

FDA records hold no clearances under product code MGQ in the trailing twelve months.

FDA records show no clearances under product code MGQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260