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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 a medical device manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under approval 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. It is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K221995.

When was Gas Insufflator approved by the FDA?

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

What company makes Gas Insufflator?

Gas Insufflator is manufactured by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..

What is the FDA product code for Gas Insufflator?

The FDA product code for Gas Insufflator is HIF.

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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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