Home / 510(k) Clearances / K811163

510(k) K811163

SUR-FIT DISPOSABLE FANGE CAP by E. R. Squibb & Sons, Inc. — Product Code EXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
April 28, 1981
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 E. R. Squibb & Sons, Inc.

  • K821494 — RIA STAT 16 (June 3, 1982)
  • K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (March 26, 1982)
  • K820340 — T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (March 4, 1982)
  • K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (March 4, 1982)
  • K811240 — SUR-FIT LOOP OSTOMY O.R. SET (June 16, 1981)
  • K811239 — SUR-FIT DISPOSABLE CONVEX INSERT (June 9, 1981)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (April 21, 1981)
  • K810211 — T3 RIA KIT (February 10, 1981)
  • K803100 — STOMAHESIVE PASTE PROTECTIVE SKIN BARR (January 8, 1981)

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)