Home / 510(k) Clearances / K820167

510(k) K820167

LAMINATED KARAYA GUM WASHERS by Atlantic Surgical — Product Code EXB

K820167 is an FDA 510(k) premarket notification submitted by Atlantic Surgical for the device "LAMINATED KARAYA GUM WASHERS". The FDA issued a decision of Substantially Equivalent on February 18, 1982. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Atlantic Surgical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1982
Date Received
January 21, 1982
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 Atlantic Surgical

  • K772366 — BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (January 26, 1978)
  • K770230 — KARAYA GUM POWDER (February 28, 1977)

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