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FDA 510(k)

EvoEndo Single-Use Endoscopy System

K-Number: K260573 · 2026-04-21

ApplicantEvoEndo, Inc.
Decision Date2026-04-21
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EvoEndo Single-Use Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is EvoEndo, Inc.. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K260573. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EvoEndo Single-Use Endoscopy System?

EvoEndo Single-Use Endoscopy System is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is EvoEndo, Inc.. The 510(k) number is K260573.

When did EvoEndo Single-Use Endoscopy System receive FDA 510(k) clearance?

EvoEndo Single-Use Endoscopy System received FDA 510(k) clearance on 2026-04-21, under 510(k) number K260573.

Who is the listed applicant for EvoEndo Single-Use Endoscopy System?

The FDA 510(k) record lists EvoEndo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EvoEndo Single-Use Endoscopy System?

The FDA product code for EvoEndo Single-Use Endoscopy System is FDS.

Related Clinical Trials

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.

NCT06200961Trans-nasal Endoscopy for Bariatric PatientsRECRUITING

Other records listing EvoEndo, Inc. 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.

K251708EvoEndo Single-Use Endoscopy SystemK250900EvoEndo Single-Use Endoscopy SystemK213606EvoEndo Single-Use Endoscopy System

Related Devices (Code: FDS)

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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, 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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