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FDA 510(k)

Mochida Nerve Cuff

K-Number: K233322 · 2024-06-21

ApplicantMochida Pharmaceutical Co., Ltd.
Decision Date2024-06-21
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mochida Nerve Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Mochida Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233322. 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 Mochida Nerve Cuff?

Mochida Nerve Cuff is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Mochida Pharmaceutical Co., Ltd.. The 510(k) number is K233322.

When did Mochida Nerve Cuff receive FDA 510(k) clearance?

Mochida Nerve Cuff received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233322.

Who is the listed applicant for Mochida Nerve Cuff?

The FDA 510(k) record lists Mochida Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mochida Nerve Cuff?

The FDA product code for Mochida Nerve Cuff is JXI.

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 BiosciencesK243889Remplir (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.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, 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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