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FDA 510(k)

AP 50/30 Insufflator with Insuflow Port

K-Number: K170799 · 2017-11-14

Decision Date2017-11-14
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AP 50/30 Insufflator with Insuflow Port is the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K170799. 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 AP 50/30 Insufflator with Insuflow Port?

AP 50/30 Insufflator with Insuflow Port is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Lexion Medical, LLC. The 510(k) number is K170799.

When did AP 50/30 Insufflator with Insuflow Port receive FDA 510(k) clearance?

AP 50/30 Insufflator with Insuflow Port received FDA 510(k) clearance on 2017-11-14, under 510(k) number K170799.

Who is the listed applicant for AP 50/30 Insufflator with Insuflow Port?

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

What is the FDA product code for AP 50/30 Insufflator with Insuflow Port?

The FDA product code for AP 50/30 Insufflator with Insuflow Port is HIF.

Other records listing Lexion Medical, LLC 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.

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

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