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510(k) K974819

SELECTCELLS(TM) MINI by Select Medical Systems, Inc. — Product Code HHK

K974819 is an FDA 510(k) premarket notification submitted by Select Medical Systems, Inc. for the device "SELECTCELLS(TM) MINI". The FDA issued a decision of Substantially Equivalent on March 23, 1998. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Select Medical Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1998
Date Received
December 23, 1997
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)
  • K954099 — SELECT IUI (November 22, 1995)
  • K954097 — SELECTCELLS STANDARD (November 21, 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)

FDA data resources