Home / 510(k) Clearances / K880306

510(k) K880306

EMERGENCY-CLEAN UP(TM) ECP by Cdc Products Corp. — Product Code EXB

K880306 is an FDA 510(k) premarket notification submitted by Cdc Products Corp. for the device "EMERGENCY-CLEAN UP(TM) ECP". The FDA issued a decision of Substantially Equivalent on May 20, 1988. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Cdc Products Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1988
Date Received
January 25, 1988
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 Cdc Products Corp.

  • K882878 — ODOR-END EMERGENCY CLEAN UP POWDER (December 8, 1988)

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)
  • 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