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510(k) K951260

URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT by Biosearch Medical Products, Inc. — Product Code KOD

K951260 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1995
Date Received
March 21, 1995
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 Biosearch Medical Products, Inc.

  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) (August 11, 1997)
  • K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (March 3, 1997)
  • K944614 — MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM (April 5, 1995)
  • K932295 — NON-BALLOON REPLACEMENT GASTROSTOMY KIT (September 8, 1994)
  • K935045 — BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER (August 19, 1994)
  • K923002 — ENTEROCLYSIS TUBE (June 28, 1994)
  • K934193 — CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST (November 19, 1993)
  • K922987 — LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. (April 23, 1993)
  • K923474 — LOW PROFILE GASTROMSTOMY DEVICE (January 5, 1993)

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