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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 Oct 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 7 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 8, 1981
Date Received
Aug 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
510(k)

Other clearances by Medi-Spec

  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (Feb 4, 1984)
  • K812694 — WHISK-R (Oct 26, 1981)
  • K801554 — STERILE CAST PADDING (Aug 4, 1980)
  • K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT (Apr 24, 1980)
  • K800490 — STERILE DRESSING PACK (Mar 12, 1980)
  • K790952 — CLAMP COVERS (Jun 5, 1979)
  • K780548 — DISPOSA-LOOPS (Aug 21, 1978)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (Oct 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (Sep 25, 2024)
  • K201952 — CrossGlide ETS Plus (Aug 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (Mar 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (Apr 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (Jul 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (Dec 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (Oct 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (Apr 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)

FDA data resources

Source: FDA 510(k) database entry for K812426. Report a data issue: hello@regdatalab.com.