510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964047Substantially Equivalent

Cryosil Silicone Gel Sheeting

Biodermis LLC, Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964047 is the FDA 510(k) clearance record for CRYOSIL SILICONE GEL SHEETING, a class II device, cleared for Biodermis Corp. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 5 510(k) clearances for Biodermis Corp., from to . As of , FDA records show no recalls naming K964047.

Clearance record

Decision date
Received
(161 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biodermis Corp. 3753 Howard Hughes Pkwy.,, Las Vegas NV
510(k) summary
Statement
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260