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FDA 510(k)

Bronchoscope System

K-Number: K231107 · 2024-02-15

ApplicantHunan Endoso Life Technology Co., Ltd.
Decision Date2024-02-15
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K231107. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bronchoscope System?

Bronchoscope System is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. The 510(k) number is K231107.

When did Bronchoscope System receive FDA 510(k) clearance?

Bronchoscope System received FDA 510(k) clearance on 2024-02-15, under 510(k) number K231107.

Who is the listed applicant for Bronchoscope System?

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

What is the FDA product code for Bronchoscope System?

The FDA product code for Bronchoscope System is EOQ.

Other records listing Hunan Endoso Life 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.

K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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.

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