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FDA 510(k)

ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT

K-Number: K090306 · 2009-06-18

ApplicantAragon Surgical, Inc.
Decision Date2009-06-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Aragon Surgical, Inc.. It received FDA 510(k) clearance on 2009-06-18 under 510(k) number K090306. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT?

ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Aragon Surgical, Inc.. The 510(k) number is K090306.

When did ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT receive FDA 510(k) clearance?

ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT received FDA 510(k) clearance on 2009-06-18, under 510(k) number K090306.

Who is the listed applicant for ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT?

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

What is the FDA product code for ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT?

The FDA product code for ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT is GEI.

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Other records listing Aragon Surgical, Inc. 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.

K110824ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENTK093075ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTK081312ARAGON ONESHOT SYSTEMK073452MODIFICATION TO: ARAGON SURGICAL LAPCAPK070651ARAGON SURGICAL LAPCAP

Related Devices (Code: GEI)

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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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