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510(k) K001545

PIPET CURET by Milex Products, Inc. — Product Code HHK

K001545 is an FDA 510(k) premarket notification submitted by Milex Products, Inc. for the device "PIPET CURET". The FDA issued a decision of Substantially Equivalent on June 15, 2000. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Milex Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2000
Date Received
May 18, 2000
Clearance Type
Special
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 Milex Products, Inc.

  • K904774 — INGLAT-O-BALL (December 7, 1990)
  • K904026 — INFLAT-O-BALL (October 10, 1990)
  • K900903 — KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE (May 3, 1990)
  • K882628 — ENDO C BRUSH (July 25, 1988)
  • K862410 — MILEX KEGEL PERINEAL EXERCISER (July 31, 1986)
  • K861385 — MILEX BARTHOLIN GLAND CATHETER (June 16, 1986)
  • K760264 — CURETTE, PROPOSED TIS-U-TRAP, METAL (October 6, 1976)

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