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510(k) K896713

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. by Advanced Surgical Intervention, Inc. — Product Code KOE

K896713 is an FDA 510(k) premarket notification submitted by Advanced Surgical Intervention, Inc. for the device "ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.". The FDA issued a decision of Substantially Equivalent on May 24, 1990. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Advanced Surgical Intervention, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1990
Date Received
November 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
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)
  • K895182 — ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY (October 24, 1989)
  • K874530 — URETHRAL DILATOR ENDOSCOPE (January 27, 1988)

Other clearances for product code KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)

FDA data resources