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FDA 510(k)

SURGISIS NERVE CUFF

K-Number: K031069 · 2003-05-15

ApplicantCook Biotech, Inc.
Decision Date2003-05-15
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGISIS NERVE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2003-05-15 under 510(k) number K031069. 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 SURGISIS NERVE CUFF?

SURGISIS NERVE CUFF is a medical device that received FDA 510(k) clearance on 2003-05-15. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K031069.

When did SURGISIS NERVE CUFF receive FDA 510(k) clearance?

SURGISIS NERVE CUFF received FDA 510(k) clearance on 2003-05-15, under 510(k) number K031069.

Who is the listed applicant for SURGISIS NERVE CUFF?

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

What is the FDA product code for SURGISIS NERVE CUFF?

The FDA product code for SURGISIS NERVE CUFF is JXI.

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Other records listing Cook Biotech, 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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIX

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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 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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