510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832318Substantially Equivalent

Isolation Bag 3M

3M Company, Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832318 is the FDA 510(k) clearance record for ISOLATION BAG 3M, a class I device, cleared for 3M Company on under FDA product code KGY (Bag, Intestine). FDA records list 13 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K832318.

Clearance record

Decision date
Received
(108 days to decision)
Product code
KGY Bag, Intestine
Regulation
21 CFR 878.4100
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
3M Company 2724 S. Peck Rd., Monrovia CA
Third party review
No

Clearances, product code KGY

Trailing 12 months

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

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