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510(k) K203820

ASPIVIX v1.1 Cervical Suction Tenaculum by Aspivix SA — Product Code HDC

K203820 is an FDA 510(k) premarket notification submitted by Aspivix SA for the device "ASPIVIX v1.1 Cervical Suction Tenaculum". The FDA issued a decision of Substantially Equivalent on August 17, 2021. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. Aspivix SA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2021
Date Received
December 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Aspivix SA

  • K223866 — Carevix™ Suction Cervical Stabilizer (January 25, 2023)

Other clearances for product code HDC

  • K223866 — Carevix™ Suction Cervical Stabilizer (January 25, 2023)
  • 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)
  • 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