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FDA 510(k)

Single-Use Flexible Rhinolaryngoscope

K-Number: K221581 · 2022-11-18

ApplicantHunan Vathin Medical Instrument Co., Ltd.
Decision Date2022-11-18
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single-Use Flexible Rhinolaryngoscope is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K221581. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-Use Flexible Rhinolaryngoscope?

Single-Use Flexible Rhinolaryngoscope is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K221581.

When did Single-Use Flexible Rhinolaryngoscope receive FDA 510(k) clearance?

Single-Use Flexible Rhinolaryngoscope received FDA 510(k) clearance on 2022-11-18, under 510(k) number K221581.

Who is the listed applicant for Single-Use Flexible Rhinolaryngoscope?

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

What is the FDA product code for Single-Use Flexible Rhinolaryngoscope?

The FDA product code for Single-Use Flexible Rhinolaryngoscope is EOB.

Other records listing Hunan Vathin Medical Instrument 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.

K250232Vathin® Video Bronchoscope SystemK251599Single-use Ureteral Access SheathK250785Single-use Flexible UreteroscopeK243117Digital Video ProcessorK242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mLK242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

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Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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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