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FDA 510(k)

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

K-Number: K161445 · 2016-08-16

ApplicantAdapta Medical, Inc.
Decision Date2016-08-16
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C is a medical device manufactured by Adapta Medical, Inc.. It received FDA 510(k) clearance on 2016-08-16 under approval number K161445. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C?

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C is a medical device that received FDA 510(k) clearance on 2016-08-16. It is manufactured by Adapta Medical, Inc.. The 510(k) number is K161445.

When was PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C approved by the FDA?

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C received FDA 510(k) clearance on 2016-08-16, under approval number K161445.

What company makes PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C?

PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C is manufactured by Adapta Medical, Inc..

What is the FDA product code for PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C?

The FDA product code for PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C is EZD.

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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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