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510(k) K872294

COMBINATION NITE DRAINAGE UNIT by Arnold Technologies — Product Code EXB

K872294 is an FDA 510(k) premarket notification submitted by Arnold Technologies for the device "COMBINATION NITE DRAINAGE UNIT". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Arnold Technologies has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
June 16, 1987
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 by Arnold Technologies

  • K870136 — PERSONAL PUNCH (April 1, 1987)

Other clearances for product code EXB

  • K252140 — Heylo™ System (October 6, 2025)
  • K181643 — SmartBag (SmartPouch) (November 16, 2018)
  • 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)
  • 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