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FDA 510(k)

PLEXUS/1000

K-Number: K943353 · 1994-12-12

ApplicantPlexus Medical
Decision Date1994-12-12
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEXUS/1000 is the device name listed in this FDA 510(k) record. The listed applicant is Plexus Medical. It received FDA 510(k) clearance on 1994-12-12 under 510(k) number K943353. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEXUS/1000?

PLEXUS/1000 is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Plexus Medical. The 510(k) number is K943353.

When did PLEXUS/1000 receive FDA 510(k) clearance?

PLEXUS/1000 received FDA 510(k) clearance on 1994-12-12, under 510(k) number K943353.

Who is the listed applicant for PLEXUS/1000?

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

What is the FDA product code for PLEXUS/1000?

The FDA product code for PLEXUS/1000 is FNM.

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 Plexus Medical 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.

K952610PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)K944411P/2000

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

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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