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510(k) K870679

VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE by Van-Tec, Inc. — Product Code FBO

K870679 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE". The FDA issued a decision of Substantially Equivalent on March 30, 1987. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
February 19, 1987
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 Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)
  • K870696 — VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH (March 30, 1987)

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)

FDA data resources