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510(k) K181643

SmartBag (SmartPouch) by 11 Health Technologies Limited — Product Code EXB

K181643 is an FDA 510(k) premarket notification submitted by 11 Health Technologies Limited for the device "SmartBag (SmartPouch)". The FDA issued a decision of Substantially Equivalent on November 16, 2018. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
June 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

Other clearances for product code EXB

  • K252140 — Heylo™ System (October 6, 2025)
  • K140938 — OSTOM-I ALERT (October 10, 2014)
  • K922730 — LAKE OSTOMY CARE SET (December 30, 1993)
  • K882878 — ODOR-END EMERGENCY CLEAN UP POWDER (December 8, 1988)
  • K881636 — CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (July 13, 1988)
  • K880306 — EMERGENCY-CLEAN UP(TM) ECP (May 20, 1988)
  • K872294 — COMBINATION NITE DRAINAGE UNIT (December 29, 1987)
  • K873929 — 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (December 3, 1987)
  • K871526 — ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (October 13, 1987)
  • K871738 — OSTO-PURE (August 12, 1987)

FDA data resources