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510(k) K001818

UTERINE TENACLUM HOOK by Towne Brothers (Pvt.), Ltd. — Product Code HDC

K001818 is an FDA 510(k) premarket notification submitted by Towne Brothers (Pvt.), Ltd. for the device "UTERINE TENACLUM HOOK". The FDA issued a decision of Substantially Equivalent on August 30, 2000. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
June 15, 2000
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

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  • 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)
  • K030078 — BURBANK TENACULUM, MODEL 09-0011-01 (January 24, 2003)
  • K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (August 27, 1999)

FDA data resources