510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951022Unknown

Circulon System Step 1

Convatec, A Division of E.R. Squibb & Sons, Princeton NJ / Traditional, Unknown
FDA source (opens on fda.gov)

K951022 is the FDA 510(k) clearance record for CIRCULON SYSTEM STEP 1, a class II device, cleared for Convatec, A Division of E.R. Squibb & Sons on under FDA product code MCY (Wound Dressing Kit). FDA's definition for product code MCY reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons, from to . As of , FDA records show no recalls naming K951022.

Clearance record

Decision date
Received
(97 days to decision)
Product code
MCY Wound Dressing Kit
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Applicant
Convatec, A Division of E.R. Squibb & Sons P.O. Box 4000, Princeton NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MCY

Trailing 12 months

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

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