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510(k) K810630

SILICONE ELASTOMER COATED LATEX FOLEY by G.D. Searle and Co. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
March 9, 1981
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 G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)
  • K802280 — WHITE KNIGHT DRAPE SEAL (October 10, 1980)

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  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
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  • 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)