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FDA 510(k)

Insufflation Retention Device

K-Number: K213773 · 2022-07-21

ApplicantBpendo, LLC
Decision Date2022-07-21
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Insufflation Retention Device is a medical device manufactured by Bpendo, LLC. It received FDA 510(k) clearance on 2022-07-21 under approval number K213773. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insufflation Retention Device?

Insufflation Retention Device is a medical device that received FDA 510(k) clearance on 2022-07-21. It is manufactured by Bpendo, LLC. The 510(k) number is K213773.

When was Insufflation Retention Device approved by the FDA?

Insufflation Retention Device received FDA 510(k) clearance on 2022-07-21, under approval number K213773.

What company makes Insufflation Retention Device?

Insufflation Retention Device is manufactured by Bpendo, LLC.

What is the FDA product code for Insufflation Retention Device?

The FDA product code for Insufflation Retention Device is FDF.

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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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