SELECTCELLS(TM) MINI— 510(k) K974819

Name: FDA 510(k) clearance K974819
Creator: U.S. Food and Drug Administration
Published: 1998-03-23

Substantially Equivalent

Select Medical Systems, Inc.

FDA 510(k) clearance K974819 for SELECTCELLS(TM) MINI, Substantially Equivalent on 1998-03-23. Applicant: Select Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Select Medical Systems, Inc.
Product code: Code HHK
Device class: Class 2
Regulation: 21 CFR 884.1175
Advisory panel: Obstetrics/Gynecology
Date received: 1997-12-23
Decision date: 1998-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williston, VT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHK

view all

K251882 — Uterine Aspiration Set2025-10-16
K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)2024-09-25
K201952 — CrossGlide ETS Plus2020-08-05
K192534 — CrossBay Endometrial Tissue Sampler (ETS)2020-03-25
K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE2011-04-14

More clearances from Select Medical Systems, Inc.

view all

K012935 — THECURVE, ITEM 5072001-10-11
K954099 — SELECT IUI1995-11-22
K954097 — SELECTCELLS STANDARD1995-11-21
K954102 — SELECTMUCUS1995-11-21
K942922 — SELECTA 20/60 CHEMISTRY ANALYZER1995-07-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.