ENDOtube— 510(k) K203350

Substantially Equivalent

Nissha Medical Technologies Sas

FDA 510(k) clearance K203350 for ENDOtube, Substantially Equivalent on 2021-09-29. Applicant: Nissha Medical Technologies Sas. Device class: 2.

Clearance details

Applicant: Nissha Medical Technologies Sas
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-11-13
Decision date: 2021-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conflans Ste Honorine, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCX

K251986 — AUXILIARY WATER TUBE MAJ-8552025-09-26
K251997 — Single-Use Biopsy Valve (MAJ-1555)2025-09-25
K242586 — ArgoCap (200.52)2025-05-22
K241704 — Endoscopic Water Pump2025-03-20
K242357 — Water Container (MAJ-901); Water Container (MAJ-902)2024-10-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.