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510(k) K800505

URETHRAL CATHETER by Medi-Craft , Ltd. — Product Code KOD

K800505 is an FDA 510(k) premarket notification submitted by Medi-Craft , Ltd. for the device "URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on April 8, 1980. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Medi-Craft , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1980
Date Received
March 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medi-Craft , Ltd.

  • K861949 — SUCTION CATHETER KIT (October 22, 1986)
  • K800507 — FEEDING TUBES (April 8, 1980)
  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K800504 — OXYGEN CONNECTING TUBES (March 18, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)

FDA data resources