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FDA 510(k)

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap

K-Number: K172575 · 2018-01-18

ApplicantBaronova, Inc.
Decision Date2018-01-18
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is the device name listed in this FDA 510(k) record. The listed applicant is Baronova, Inc.. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K172575. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Baronova, Inc.. The 510(k) number is K172575.

When did BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap receive FDA 510(k) clearance?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap received FDA 510(k) clearance on 2018-01-18, under 510(k) number K172575.

Who is the listed applicant for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

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

What is the FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

The FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is FED.

Other records listing Baronova, 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.

K191078BAROnova Access Sheath KitK190985BAROnova Insufflation System, BAROnova Accessory KitPMA P180024IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

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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