510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912765Substantially Equivalent

Stasis Button Prssure Device

Arch Development Group, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912765 is the FDA 510(k) clearance record for STASIS BUTTON PRSSURE DEVICE, a class I device, cleared for Arch Development Group on under FDA product code MHW (Dressing, Compression). FDA records list 2 510(k) clearances for Arch Development Group, from to . As of , FDA records show no recalls naming K912765.

Clearance record

Decision date
Received
(49 days to decision)
Product code
MHW Dressing, Compression
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Applicant
Arch Development Group 9648 Olive Blvd., Suite 411, St. Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code MHW

Trailing 12 months

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

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