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FDA 510(k)

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

K-Number: K152557 · 2016-02-23

ApplicantG21, S.R.L.
Decision Date2016-02-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152557. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is G21, S.R.L.. The 510(k) number is K152557.

When did Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters receive FDA 510(k) clearance?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152557.

Who is the listed applicant for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is NDN.

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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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