Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MICROSTIM 100 MODEL 2C

K-Number: K910580 · 1991-06-20

ApplicantMicrostim, Inc.
Decision Date1991-06-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROSTIM 100 MODEL 2C is the device name listed in this FDA 510(k) record. The listed applicant is Microstim, Inc.. It received FDA 510(k) clearance on 1991-06-20 under 510(k) number K910580. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSTIM 100 MODEL 2C?

MICROSTIM 100 MODEL 2C is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is Microstim, Inc.. The 510(k) number is K910580.

When did MICROSTIM 100 MODEL 2C receive FDA 510(k) clearance?

MICROSTIM 100 MODEL 2C received FDA 510(k) clearance on 1991-06-20, under 510(k) number K910580.

Who is the listed applicant for MICROSTIM 100 MODEL 2C?

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

What is the FDA product code for MICROSTIM 100 MODEL 2C?

The FDA product code for MICROSTIM 100 MODEL 2C is GZJ.

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 Microstim, 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.

K010295MICROSTIM 100I TENS DEVICE

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.

↑