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510(k) K874530

URETHRAL DILATOR ENDOSCOPE by Advanced Surgical Intervention, Inc. — Product Code KOB

K874530 is an FDA 510(k) premarket notification submitted by Advanced Surgical Intervention, Inc. for the device "URETHRAL DILATOR ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Advanced Surgical Intervention, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
November 3, 1987
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 Advanced Surgical Intervention, Inc.

  • K954215 — MINIGUARD (May 8, 1996)
  • K926110 — ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT (July 8, 1993)
  • K930361 — ASI CYSTOLASE LASER CYSTOSCOPE (April 29, 1993)
  • K921990 — ASI UROPLASTY LASER CYSTOSCOPE (October 28, 1992)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)
  • K901336 — ASI HEMOSTASIS CATHETER (June 20, 1990)
  • K896713 — ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. (May 24, 1990)
  • K895182 — ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY (October 24, 1989)

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