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FDA 510(k)

Insufflator

K-Number: K222812 · 2023-05-16

Decision Date2023-05-16
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222812. 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 Insufflator?

Insufflator is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K222812.

When did Insufflator receive FDA 510(k) clearance?

Insufflator received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222812.

Who is the listed applicant for Insufflator?

The FDA 510(k) record lists Scivita Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insufflator?

The FDA product code for Insufflator is HIF.

Other records listing Scivita Medical Technology Co., Ltd. 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.

View all 13 devices →

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.

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.