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510(k) K853216

MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 by Gyneco, Inc. — Product Code HHK

K853216 is an FDA 510(k) premarket notification submitted by Gyneco, Inc. for the device "MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4". The FDA issued a decision of Substantially Equivalent on April 2, 1986. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Gyneco, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1986
Date Received
August 1, 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 Gyneco, Inc.

  • K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE (May 5, 1986)
  • K852357 — GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (July 5, 1985)
  • K843941 — ENDOCYTE (February 25, 1985)
  • K841275 — FINE NEEDLE ASPIRATION DEVICE (August 17, 1984)

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