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FDA 510(k)

LaparoLight Veress Needle

K-Number: K171139 · 2017-05-18

ApplicantBuffalo Filter, LLC
Decision Date2017-05-18
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LaparoLight Veress Needle is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Filter, LLC. It received FDA 510(k) clearance on 2017-05-18 under 510(k) number K171139. 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 LaparoLight Veress Needle?

LaparoLight Veress Needle is a medical device that received FDA 510(k) clearance on 2017-05-18. The listed applicant is Buffalo Filter, LLC. The 510(k) number is K171139.

When did LaparoLight Veress Needle receive FDA 510(k) clearance?

LaparoLight Veress Needle received FDA 510(k) clearance on 2017-05-18, under 510(k) number K171139.

Who is the listed applicant for LaparoLight Veress Needle?

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

What is the FDA product code for LaparoLight Veress Needle?

The FDA product code for LaparoLight Veress Needle is HIF.

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.

K252584Insufflator (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 CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

Official Source

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