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510(k) K990387

ENDOMETRIAL SAMPLER by U.A. Medical Products, Inc. — Product Code HHK

K990387 is an FDA 510(k) premarket notification submitted by U.A. Medical Products, Inc. for the device "ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on April 20, 1999. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1999
Date Received
February 8, 1999
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 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