510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901182Unknown

Enema Bag Set

Orion Life Systems, Inc., Wheeling IL / Traditional, Unknown
FDA source (opens on fda.gov)

K901182 is the FDA 510(k) clearance record for ENEMA BAG SET, a class I device, cleared for Orion Life Systems, Inc. on under FDA product code FCE (Enema Kit). FDA's definition for product code FCE 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 guidance...". FDA records list 33 510(k) clearances for Orion Life Systems, Inc., from to . As of , FDA records show no recalls naming K901182.

Clearance record

Decision date
Received
(107 days to decision)
Product code
FCE Enema Kit
Regulation
21 CFR 876.5210
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Orion Life Systems, Inc. 124 Messner Dr., Wheeling IL
Third party review
No

Clearances, product code FCE

Trailing 12 months

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

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