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510(k) K031358

TRANSVAGINAL DOPPLER PROBE by Vascular Control Systems, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2003
Date Received
April 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Vascular Control Systems, Inc.

  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • K052209 — VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 (September 6, 2005)
  • K032125 — CSTAT, MODELS 09-0014-01 AND 09-0014-02 (February 9, 2004)
  • K031812 — TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (December 12, 2003)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K023154 — VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 (December 20, 2002)
  • K023024 — TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 (September 26, 2002)
  • K011863 — VCS-A SERIES CLAMP (February 15, 2002)

Other clearances for product code ITX

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  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)