510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K970439Substantially Equivalent

Proxiderm (D-460,D 90 460,D 180,460, Ps 460)

Progressive Surgical Products, Inc., Westbury NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970439 is the FDA 510(k) clearance record for PROXIDERM (D-460,D 90 460,D 180,460, PS 460), a class I device, cleared for Progressive Surgical Products, Inc. on under FDA product code MKY (System, Skin Closure). FDA records list 3 510(k) clearances for Progressive Surgical Products, Inc., from to . As of , FDA records show no recalls naming K970439.

Clearance record

Decision date
Received
(70 days to decision)
Product code
MKY System, Skin Closure
Regulation
21 CFR 878.4320
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Progressive Surgical Products, Inc. 694 Main St., Westbury NY
510(k) summary
Statement
Third party review
No

Clearances, product code MKY

Trailing 12 months

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

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