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FDA 510(k)

SELECTCELLS(TM) MINI

K-Number: K974819 · 1998-03-23

ApplicantSelect Medical Systems, Inc.
Decision Date1998-03-23
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SELECTCELLS(TM) MINI is the device name listed in this FDA 510(k) record. The listed applicant is Select Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-03-23 under 510(k) number K974819. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTCELLS(TM) MINI?

SELECTCELLS(TM) MINI is a medical device that received FDA 510(k) clearance on 1998-03-23. The listed applicant is Select Medical Systems, Inc.. The 510(k) number is K974819.

When did SELECTCELLS(TM) MINI receive FDA 510(k) clearance?

SELECTCELLS(TM) MINI received FDA 510(k) clearance on 1998-03-23, under 510(k) number K974819.

Who is the listed applicant for SELECTCELLS(TM) MINI?

The FDA 510(k) record lists Select Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELECTCELLS(TM) MINI?

The FDA product code for SELECTCELLS(TM) MINI is HHK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Select Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012935THECURVE, ITEM 507K954099SELECT IUIK954102SELECTMUCUSK954097SELECTCELLS STANDARDK942922SELECTA 20/60 CHEMISTRY ANALYZER

Related Devices (Code: HHK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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