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510(k) K954097

SELECTCELLS STANDARD by Select Medical Systems, Inc. — Product Code HHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1995
Date Received
August 31, 1995
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 Select Medical Systems, Inc.

  • K012935 — THECURVE, ITEM 507 (October 11, 2001)
  • K974819 — SELECTCELLS(TM) MINI (March 23, 1998)
  • K954099 — SELECT IUI (November 22, 1995)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K942922 — SELECTA 20/60 CHEMISTRY ANALYZER (July 19, 1995)

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)