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510(k) K020628

CURELLE, PREFERRED CURELLE, CUTEQ 2.5 by Bioteque America, Inc. — Product Code HHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2002
Date Received
February 26, 2002
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 Bioteque America, Inc.

  • K041094 — HSG CATHETER SET (June 17, 2004)
  • K013289 — BIOTEQUE VAGINAL PESSARIES (December 27, 2001)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)
  • K920747 — PESSARY FLEXIBLE SILICONE DONUT RING (August 29, 1994)
  • K933628 — CYTOLOGY BRUSH (March 11, 1994)
  • K933521 — SPECULUM (March 7, 1994)
  • K920187 — FLEXIBLE SILICONE GELIHORN (October 23, 1992)
  • K920177 — VERSA-VIAL (July 13, 1992)

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)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)