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FDA 510(k)

EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV

K-Number: K060563 · 2006-06-02

ApplicantPajunk GmbH
Decision Date2006-06-02
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2006-06-02 under 510(k) number K060563. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV?

EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV is a medical device that received FDA 510(k) clearance on 2006-06-02. The listed applicant is Pajunk GmbH. The 510(k) number is K060563.

When did EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV receive FDA 510(k) clearance?

EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV received FDA 510(k) clearance on 2006-06-02, under 510(k) number K060563.

Who is the listed applicant for EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV?

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

What is the FDA product code for EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV?

The FDA product code for EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV is CAZ.

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Other records listing Pajunk GmbH 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.

K113207SONO TAP, TUOHY SONOK113209CHIBA SONOK053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETK053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPK043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSK042979MODIFICATION TO: PLEXALONG SETS

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Related Devices (Code: CAZ)

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.

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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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