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510(k) K941992

CYSTOSCOPE by Surgical Technologies, Inc. — Product Code FBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1995
Date Received
April 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Surgical Technologies, Inc.

  • K942029 — ARTHROSCOPE (November 8, 1995)
  • K946136 — INFINITECH LIGHTED INFUSION CANNULA (October 2, 1995)
  • K952566 — OSCILFLATOR (August 31, 1995)
  • K951918 — SURGICAL TECHNOLOGIES, INC. SYRINGE (July 20, 1995)
  • K950683 — ARTHROGRAM TRAY (May 6, 1995)
  • K946135 — INFINITECH ASPIRATING LASER PROBE (April 18, 1995)
  • K946181 — INFINITECH SOFT TIP FLUTE NEEDLE (March 14, 1995)
  • K942030 — BIOPSY SCISSORS (June 27, 1994)
  • K942482 — PRESSURE MONITORING EXTENSION (June 14, 1994)
  • K941161 — FLEXIBLE GRASPING FORCEPS (May 4, 1994)

Other clearances for product code FBO

  • K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fibersc (May 2, 2025)
  • K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (November 27, 2024)
  • K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (January 2, 2014)
  • K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND C (October 10, 2008)
  • K080780 — ANCHORAGE SCOPE, MODEL 000003 (July 30, 2008)
  • K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (January 17, 2007)
  • K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (June 27, 2006)
  • K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT (August 10, 2001)
  • K972979 — SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI (December 11, 1997)
  • K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (December 20, 1996)