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FDA 510(k)

MODIFICATION TO: ARAGON SURGICAL LAPCAP

K-Number: K073452 · 2008-01-11

ApplicantAragon Surgical, Inc.
Decision Date2008-01-11
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ARAGON SURGICAL LAPCAP 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 2008-01-11 under 510(k) number K073452. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ARAGON SURGICAL LAPCAP?

MODIFICATION TO: ARAGON SURGICAL LAPCAP is a medical device that received FDA 510(k) clearance on 2008-01-11. The listed applicant is Aragon Surgical, Inc.. The 510(k) number is K073452.

When did MODIFICATION TO: ARAGON SURGICAL LAPCAP receive FDA 510(k) clearance?

MODIFICATION TO: ARAGON SURGICAL LAPCAP received FDA 510(k) clearance on 2008-01-11, under 510(k) number K073452.

Who is the listed applicant for MODIFICATION TO: ARAGON SURGICAL LAPCAP?

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 MODIFICATION TO: ARAGON SURGICAL LAPCAP?

The FDA product code for MODIFICATION TO: ARAGON SURGICAL LAPCAP is HIF.

Related Clinical Trials

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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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 INSTRUMENTK090306ARAGON SURGICAL RF SYSTEM L2 INSTRUMENTK081312ARAGON ONESHOT SYSTEMK070651ARAGON SURGICAL LAPCAP

Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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