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510(k) K875383

LAKE CATHETER CARE KITS (MODIFICATION) by Lake Medical Products, Inc. — Product Code KOD

K875383 is an FDA 510(k) premarket notification submitted by Lake Medical Products, Inc. for the device "LAKE CATHETER CARE KITS (MODIFICATION)". The FDA issued a decision of Substantially Equivalent (with conditions) on March 9, 1988. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Lake Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
March 9, 1988
Date Received
December 15, 1987
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 Lake Medical Products, Inc.

  • K943162 — LAKE STAGEZERO(TM) AIR FLOTATION BED (February 27, 1995)
  • K922730 — LAKE OSTOMY CARE SET (December 30, 1993)
  • K905053 — STAGE ZERO AIR FLOTATION BED (November 26, 1990)
  • K901835 — LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) (September 5, 1990)
  • K902508 — LAKE MALE EXTERNAL CATHETERIZATION KIT (August 23, 1990)
  • K902121 — LAKE GASTROSTOMY TUBE (July 27, 1990)
  • K884127 — LAKE N/G FEEDING TUBE (February 8, 1989)
  • K884128 — LAKE N/G EXTENSION SET (December 8, 1988)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K880578 — LAKE DISPOSABLE PROBE COVER (March 31, 1988)

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