510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181643Substantially Equivalent

SmartBag (SmartPouch)

11 Health Technologies Limited, Borehamwood, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181643 is the FDA 510(k) clearance record for SmartBag (SmartPouch), a class I device, cleared for 11 Health Technologies Limited on under FDA product code EXB (Collector, Ostomy). FDA records list one 510(k) clearance for 11 Health Technologies Limited. As of , FDA records show no recalls naming K181643.

Clearance record

Decision date
Received
(147 days to decision)
Product code
EXB Collector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
11 Health Technologies Limited The Kinetic Business Centre, Theobald St., Borehamwood, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EXB

Trailing 12 months

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

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