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510(k) K030078

BURBANK TENACULUM, MODEL 09-0011-01 by Vascular Control Systems, Inc. — Product Code HDC

K030078 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "BURBANK TENACULUM, MODEL 09-0011-01". The FDA issued a decision of Substantially Equivalent on January 24, 2003. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. Vascular Control Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
January 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
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)
  • K031358 — TRANSVAGINAL DOPPLER PROBE (May 9, 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 HDC

  • K223866 — Carevix™ Suction Cervical Stabilizer (January 25, 2023)
  • K203820 — ASPIVIX v1.1 Cervical Suction Tenaculum (August 17, 2021)
  • K142204 — Bioceptive Suction Cervical Retractor (December 19, 2014)
  • K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS (November 21, 2008)
  • K073182 — GYN DISPOSABLES TENACULUM 356T (November 28, 2007)
  • K062563 — FEMTEN CERVICAL TENACULUM (May 18, 2007)
  • K060573 — BURBANK TENACULUM (April 21, 2006)
  • K032585 — TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (January 9, 2004)
  • K001818 — UTERINE TENACLUM HOOK (August 30, 2000)
  • K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (August 27, 1999)

FDA data resources