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FDA 510(k)

Caprolon

K-Number: K181320 · 2018-09-18

ApplicantResorba Medical GmbH
Decision Date2018-09-18
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Caprolon is the device name listed in this FDA 510(k) record. The listed applicant is Resorba Medical GmbH. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181320. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caprolon?

Caprolon is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Resorba Medical GmbH. The 510(k) number is K181320.

When did Caprolon receive FDA 510(k) clearance?

Caprolon received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181320.

Who is the listed applicant for Caprolon?

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

What is the FDA product code for Caprolon?

The FDA product code for Caprolon is GAM.

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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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