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510(k) K896713

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

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)

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  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)