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FDA 510(k)

ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT

K-Number: K110824 · 2011-07-11

ApplicantAragon Surgical, Inc.
Decision Date2011-07-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC 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 2011-07-11 under 510(k) number K110824. 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 - 5MM LAPAROSCOPIC INSTRUMENT?

ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 2011-07-11. The listed applicant is Aragon Surgical, Inc.. The 510(k) number is K110824.

When did ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT receive FDA 510(k) clearance?

ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT received FDA 510(k) clearance on 2011-07-11, under 510(k) number K110824.

Who is the listed applicant for ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC 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 - 5MM LAPAROSCOPIC INSTRUMENT?

The FDA product code for ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC 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.

K093075ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTK090306ARAGON SURGICAL RF SYSTEM L2 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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