Home / 510(k) Clearances / K800750

510(k) K800750

STOMAHESIVE STERILE WAFER by Squibb & Sons, Inc. — Product Code EXB

K800750 is an FDA 510(k) premarket notification submitted by Squibb & Sons, Inc. for the device "STOMAHESIVE STERILE WAFER". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Squibb & Sons, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 4, 1980
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 Squibb & Sons, Inc.

  • K821174 — TSH-SQUIBB RADIOIMMUNOASSAY KIT (May 14, 1982)
  • K801424 — ESTRIOL RIA KIT FOR USE WITH GAMMAFLO (July 21, 1980)
  • K770726 — RIA KIT, T4 CLASP (April 28, 1977)
  • K761267 — ANGIOTENSIN I IMMUTOPE KIT (December 30, 1976)

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