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510(k) K871738

OSTO-PURE by Clearchem Corp. — Product Code EXB

K871738 is an FDA 510(k) premarket notification submitted by Clearchem Corp. for the device "OSTO-PURE". The FDA issued a decision of Substantially Equivalent on August 12, 1987. 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
August 12, 1987
Date Received
May 5, 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 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)
  • 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)

FDA data resources