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510(k) K854415

ENDOMETRIAL PIPELLE by Unimar, Inc. — Product Code HHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1986
Date Received
November 4, 1985
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 Unimar, Inc.

  • K932432 — KRONNER REINFORCING STYLETTE (April 12, 1994)
  • K920803 — HSG TRAY (October 19, 1992)
  • K910317 — UNI-SEM(TM) (May 1, 1991)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

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)