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

FDA 510(k)

PENTAX Medical VIVIDEO ENT Videoscope Solution

K-Number: K171011 · 2018-07-18

ApplicantPentax Medical
Decision Date2018-07-18
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical VIVIDEO ENT Videoscope Solution is a medical device manufactured by Pentax Medical. It received FDA 510(k) clearance on 2018-07-18 under approval number K171011. 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 PENTAX Medical VIVIDEO ENT Videoscope Solution?

PENTAX Medical VIVIDEO ENT Videoscope Solution is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Pentax Medical. The 510(k) number is K171011.

When was PENTAX Medical VIVIDEO ENT Videoscope Solution approved by the FDA?

PENTAX Medical VIVIDEO ENT Videoscope Solution received FDA 510(k) clearance on 2018-07-18, under approval number K171011.

What company makes PENTAX Medical VIVIDEO ENT Videoscope Solution?

PENTAX Medical VIVIDEO ENT Videoscope Solution is manufactured by Pentax Medical.

What is the FDA product code for PENTAX Medical VIVIDEO ENT Videoscope Solution?

The FDA product code for PENTAX Medical VIVIDEO ENT Videoscope Solution is EOB.

Related Clinical Trials

NCT07611708 Lubricin-inspired Osteoarthritis Treatment: a Unique Solution NOT_YET_RECRUITING NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT07267689 Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07558330 Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

Other Devices by Pentax Medical

K163614PENTAX Medical ED34-i10T, Video Duodenoscope K172156PENTAX Medical EPK-3000 Video Imaging System K161222PENTAX MEDICAL ED-3490TK, Video Duodenoscope K192280PENTAX Medical ED-3490TK Video Duodenoscope

Related Devices (Code: EOB)

K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH K153009ULTRA TelescopesOlympus Winter & Ibe GmbH K152531InstaClear Lens CleanerGyrus Acmi, Inc. K170453Medrobotics Flex Robotic SystemMedrobotics Corporation K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. K170285AED SinuscopeNational Advanced Endoscopy Devices, 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.

↑