AP50/30 Insufflator with Insuflow Port
K-Number: K191780 · 2019-08-28
ApplicantLexion Medical, LLC
Decision Date2019-08-28
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
AP50/30 Insufflator with Insuflow Port is a medical device manufactured by Lexion Medical, LLC. It received FDA 510(k) clearance on 2019-08-28 under approval number K191780. 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 AP50/30 Insufflator with Insuflow Port?
AP50/30 Insufflator with Insuflow Port is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Lexion Medical, LLC. The 510(k) number is K191780.
When was AP50/30 Insufflator with Insuflow Port approved by the FDA?
AP50/30 Insufflator with Insuflow Port received FDA 510(k) clearance on 2019-08-28, under approval number K191780.
What company makes AP50/30 Insufflator with Insuflow Port?
AP50/30 Insufflator with Insuflow Port is manufactured by Lexion Medical, LLC.
What is the FDA product code for AP50/30 Insufflator with Insuflow Port?
The FDA product code for AP50/30 Insufflator with Insuflow Port 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.