Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2019-08-28 under 510(k) 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. The listed applicant is Lexion Medical, LLC. The 510(k) number is K191780.

When did AP50/30 Insufflator with Insuflow Port receive FDA 510(k) clearance?

AP50/30 Insufflator with Insuflow Port received FDA 510(k) clearance on 2019-08-28, under 510(k) number K191780.

Who is the listed applicant for AP50/30 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 AP50/30 Insufflator with Insuflow Port?

The FDA product code for AP50/30 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.

K170799AP 50/30 Insufflator with Insuflow Port

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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.

↑