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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 a medical device manufactured by Resorba Medical GmbH. It received FDA 510(k) clearance on 2018-09-18 under approval 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. It is manufactured by Resorba Medical GmbH. The 510(k) number is K181320.

When was Caprolon approved by the FDA?

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

What company makes Caprolon?

Caprolon is manufactured by Resorba Medical GmbH.

What is the FDA product code for Caprolon?

The FDA product code for Caprolon is GAM.

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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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