Home / 510(k) Clearances / K812426

510(k) K812426

UTERINE ASPIRATION CURETTES(RIGID&FLEX) by Medi-Spec — Product Code HHK

K812426 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "UTERINE ASPIRATION CURETTES(RIGID&FLEX)". The FDA issued a decision of Substantially Equivalent on October 8, 1981. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Medi-Spec has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1981
Date Received
August 25, 1981
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 Medi-Spec

  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K812694 — WHISK-R (October 26, 1981)
  • K801554 — STERILE CAST PADDING (August 4, 1980)
  • K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT (April 24, 1980)
  • K800490 — STERILE DRESSING PACK (March 12, 1980)
  • K790952 — CLAMP COVERS (June 5, 1979)
  • K780548 — DISPOSA-LOOPS (August 21, 1978)

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)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • 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)

FDA data resources