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510(k) K863282

CARE + PLUS CATHETER CARE TRAY by Welmed Systems, Inc. — Product Code KOD

K863282 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "CARE + PLUS CATHETER CARE TRAY". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
August 25, 1986
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 Welmed Systems, Inc.

  • K863281 — CARE + PLUS IRREGATION TRAY (October 31, 1986)
  • K863497 — SUCTION CATHETER KIT (October 6, 1986)
  • K863284 — I.V. START KIT (September 22, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

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