Home / 510(k) Clearances / K051294

510(k) K051294

FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 by Femspec LLC — Product Code HHK

K051294 is an FDA 510(k) premarket notification submitted by Femspec LLC for the device "FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1". The FDA issued a decision of Substantially Equivalent on December 21, 2005. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Femspec LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2005
Date Received
May 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type

Other clearances by Femspec LLC

  • K060320 — FEMECC ENDOCERVICAL CURETTE (July 28, 2006)
  • K052192 — FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I (February 2, 2006)
  • K041757 — FEMSPEC DISPOSABLE VAGINAL SPECULUM (December 23, 2004)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)

FDA data resources