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FDA 510(k)

INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP

K-Number: K071669 · 2007-08-17

ApplicantIntegra Radionics, Inc.
Decision Date2007-08-17
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Integra Radionics, Inc.. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K071669. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP?

INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Integra Radionics, Inc.. The 510(k) number is K071669.

When did INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP receive FDA 510(k) clearance?

INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP received FDA 510(k) clearance on 2007-08-17, under 510(k) number K071669.

Who is the listed applicant for INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP?

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

What is the FDA product code for INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP?

The FDA product code for INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP is LFL.

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Related Devices (Code: LFL)

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.

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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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