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510(k) K073182

GYN DISPOSABLES TENACULUM 356T by Gyn-Disposables, Inc. — Product Code HDC

K073182 is an FDA 510(k) premarket notification submitted by Gyn-Disposables, Inc. for the device "GYN DISPOSABLES TENACULUM 356T". The FDA issued a decision of Substantially Equivalent on November 28, 2007. 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
November 28, 2007
Date Received
November 13, 2007
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 for product code HDC

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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)
  • 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