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FDA 510(k)

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

K-Number: K172214 · 2017-08-23

ApplicantG-21 S.R.L.
Decision Date2017-08-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Modified 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 G-21 S.R.L.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K172214. 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 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is G-21 S.R.L.. The 510(k) number is K172214.

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

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2017-08-23, under 510(k) number K172214.

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

The FDA 510(k) record lists G-21 S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

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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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