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FDA 510(k)

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810

K-Number: K030053 · 2003-03-31

ApplicantJomed AG
Decision Date2003-03-31
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 is the device name listed in this FDA 510(k) record. The listed applicant is Jomed AG. It received FDA 510(k) clearance on 2003-03-31 under 510(k) number K030053. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810?

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 is a medical device that received FDA 510(k) clearance on 2003-03-31. The listed applicant is Jomed AG. The 510(k) number is K030053.

When did JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 receive FDA 510(k) clearance?

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 received FDA 510(k) clearance on 2003-03-31, under 510(k) number K030053.

Who is the listed applicant for JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810?

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

What is the FDA product code for JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810?

The FDA product code for JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 is FGE.

Related Clinical Trials

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Other records listing Jomed AG 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.

K020854MODIFICATION TO FOX PTA CATHETERK010838FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008

Related Devices (Code: FGE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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