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FDA 510(k)

Gas Insufflator

K-Number: K221995 · 2023-03-28

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2023-03-28
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Gas Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K221995. 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 Gas Insufflator?

Gas Insufflator is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K221995.

When did Gas Insufflator receive FDA 510(k) clearance?

Gas Insufflator received FDA 510(k) clearance on 2023-03-28, under 510(k) number K221995.

Who is the listed applicant for Gas Insufflator?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gas Insufflator?

The FDA product code for Gas Insufflator is HIF.

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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