510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861285Substantially Equivalent

Skin Mesh Device

Precision Modified Devices, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861285 is the FDA 510(k) clearance record for SKIN MESH DEVICE, a class I device, cleared for Precision Modified Devices on under FDA product code GFD (Dermatome). FDA records list one 510(k) clearance for Precision Modified Devices. As of , FDA records show no recalls naming K861285.

Clearance record

Decision date
Received
(10 days to decision)
Product code
GFD Dermatome
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Precision Modified Devices 1239 E. 3800 S., Salt Lake City UT
Third party review
No

Clearances, product code GFD

Trailing 12 months

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

FDA records show no clearances under product code GFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFD, 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