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510(k) K060573

BURBANK TENACULUM by Vascular Control Systems, Inc. — Product Code HDC

K060573 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "BURBANK TENACULUM". The FDA issued a decision of Substantially Equivalent on April 21, 2006. 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
April 21, 2006
Date Received
March 6, 2006
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.

  • 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)
  • 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 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)
  • K032585 — TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (January 9, 2004)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K001818 — UTERINE TENACLUM HOOK (August 30, 2000)
  • K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (August 27, 1999)

FDA data resources