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FDA 510(k)

PIEZOELECTRIC SYSTEM

K-Number: K100410 · 2010-04-28

ApplicantSatelec
Decision Date2010-04-28
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIEZOELECTRIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2010-04-28 under 510(k) number K100410. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOELECTRIC SYSTEM?

PIEZOELECTRIC SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-28. The listed applicant is Satelec. The 510(k) number is K100410.

When did PIEZOELECTRIC SYSTEM receive FDA 510(k) clearance?

PIEZOELECTRIC SYSTEM received FDA 510(k) clearance on 2010-04-28, under 510(k) number K100410.

Who is the listed applicant for PIEZOELECTRIC SYSTEM?

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

What is the FDA product code for PIEZOELECTRIC SYSTEM?

The FDA product code for PIEZOELECTRIC SYSTEM is JDX.

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Other records listing Satelec as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110379AIR-N-GOK091331PIEZOTOME 2K091252IMPLANT CENTER 2K082116HEMOSTASYL PASTEK072181MINI LED AUTOFOCUSK071965I-SURGE

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Related Devices (Code: JDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.K132848PIEZOSURGERY FLEXMectron S.P.A.K093805OSCAR 3Orthosonics, Ltd.

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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