Home / 510(k) Clearances / K770408

510(k) K770408

KARAYA GUM POWDER, OSTOMY by Howmedica Corp. — Product Code EZK

K770408 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "KARAYA GUM POWDER, OSTOMY". The FDA issued a decision of Substantially Equivalent on March 15, 1977. The device falls under product code EZK (Catheter, Retention Type), a Class II device regulated under 21 CFR 876.5980. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1977
Date Received
March 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code EZK

  • K911349 — E-Z-EM ENTEROCLYSIS CATHETER SET (November 16, 1992)
  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)

FDA data resources