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510(k) K800607

SUPRAPUBIC TROCAR by G.D. Searle and Co. — Product Code KOB

K800607 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "SUPRAPUBIC TROCAR". The FDA issued a decision of Substantially Equivalent on April 8, 1980. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
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)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 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)

Other clearances for product code KOB

  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K181097 — Cook Cystostomy Catheter Set (January 18, 2019)
  • K182709 — One-Step Suprapubic Introducer (December 26, 2018)
  • K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (October 30, 2018)
  • K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET (January 17, 2014)
  • K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SY (October 26, 2012)
  • K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (March 4, 2002)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)

FDA data resources