EvoEndo Single-Use Endoscopy System

FDA 510(k) K250900 · EvoEndo, Inc.

Substantially Equivalent

510(k) numberK250900

Submission

Device name
EvoEndo Single-Use Endoscopy System
Applicant
EvoEndo, Inc.
Grayslake, IL, US
Received
March 25, 2025
Decision date
June 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FDS – Gastroscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code FDS

510(k)DeviceApplicantDecision
K260856Disposable Distal Attachment D-201-13404FDS · Traditional Olympus Medical Systems Corporation08/27/2026SE
K260824Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional Olympus Medical Systems Corporation08/27/2026SE
K253702Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional Intuitive Surgical, Inc.08/07/2026SE
K260573EvoEndo Single-Use Endoscopy SystemFDS · Traditional EvoEndo, Inc.04/21/2026SE
K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional Fujifilm Corporation02/17/2026SE
K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special Fujifilm Corporation02/06/2026SE
K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional Pentax of America, Inc.12/16/2025SE
K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional Actuated Medical, Inc.10/31/2025SE
K251708EvoEndo Single-Use Endoscopy SystemFDS · Traditional EvoEndo, Inc.10/10/2025SE
K243388Disposable Distal CapFDS · Traditional Micro-Tech (Nanjing) Co., Ltd.06/27/2025SE

More from Micro-Tech (Nanjing) Co., Ltd.

510(k)DeviceDecision
K260573EvoEndo Single-Use Endoscopy SystemFDS · Traditional 04/21/2026SE
K251708EvoEndo Single-Use Endoscopy SystemFDS · Traditional 10/10/2025SE
K213606EvoEndo Single-Use Endoscopy SystemFDS · Traditional 02/14/2022SE

Questions and answers

When was EvoEndo Single-Use Endoscopy System cleared by the FDA?

EvoEndo Single-Use Endoscopy System (K250900) received a 510(k) decision of Substantially Equivalent on June 16, 2025, 83 days after the submission was received.

What is the product code of K250900?

The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.