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FDA 510(k)

FASTUBE NERVE REGENERATION DEVICE

K-Number: K850785 · 1985-07-10

ApplicantResearch Medical, Inc.
Decision Date1985-07-10
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FASTUBE NERVE REGENERATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1985-07-10 under 510(k) number K850785. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTUBE NERVE REGENERATION DEVICE?

FASTUBE NERVE REGENERATION DEVICE is a medical device that received FDA 510(k) clearance on 1985-07-10. The listed applicant is Research Medical, Inc.. The 510(k) number is K850785.

When did FASTUBE NERVE REGENERATION DEVICE receive FDA 510(k) clearance?

FASTUBE NERVE REGENERATION DEVICE received FDA 510(k) clearance on 1985-07-10, under 510(k) number K850785.

Who is the listed applicant for FASTUBE NERVE REGENERATION DEVICE?

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

What is the FDA product code for FASTUBE NERVE REGENERATION DEVICE?

The FDA product code for FASTUBE NERVE REGENERATION DEVICE is JXI.

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Related Devices (Code: JXI)

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.

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.

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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