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)

FMS HIGH FLOW ARTHRO-SHEATH

K-Number: K951702 · 1995-05-12

ApplicantFuture Medical Systems, Inc.
Decision Date1995-05-12
Product CodeHNX
Advisory CommitteeOP
DecisionSubstantially Equivalent for Some Indications

Device Summary

FMS HIGH FLOW ARTHRO-SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Future Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K951702. The device is classified under product code HNX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FMS HIGH FLOW ARTHRO-SHEATH?

FMS HIGH FLOW ARTHRO-SHEATH is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Future Medical Systems, Inc.. The 510(k) number is K951702.

When did FMS HIGH FLOW ARTHRO-SHEATH receive FDA 510(k) clearance?

FMS HIGH FLOW ARTHRO-SHEATH received FDA 510(k) clearance on 1995-05-12, under 510(k) number K951702.

Who is the listed applicant for FMS HIGH FLOW ARTHRO-SHEATH?

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

What is the FDA product code for FMS HIGH FLOW ARTHRO-SHEATH?

The FDA product code for FMS HIGH FLOW ARTHRO-SHEATH is HNX.

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 Future 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.

K023963ADHOC CLAWK021030TITANIUM CANNULATED INTERFERENCE SCREWK013685PLLA CANNULATED INTERFERENCE SCREWK002040FMS SOLOK980808ENDO FMS UROLOGYK955500FMS ARTHOPROBE

View all 12 devices →

Related Devices (Code: HNX)

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.

K951701FMS ARTHRO-CUTTERFuture Medical Systems, 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.

↑