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510(k) K945480

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER by Harry A. Schlakman — Product Code KOB

K945480 is an FDA 510(k) premarket notification submitted by Harry A. Schlakman for the device "MOSS(R) STEEL BREAKAWAY(R) INTRODUCER". The FDA issued a decision of Substantially Equivalent on August 28, 1995. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Harry A. Schlakman has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
November 8, 1994
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 Harry A. Schlakman

  • K951122 — CAPITOL URINE DRUG SCREEN COLLECTION KIT (May 5, 1995)

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