EndoColibri— 510(k) K260356

Substantially Equivalent

Koehrer Medical Engineering GmbH

FDA 510(k) clearance K260356 for EndoColibri, Substantially Equivalent on 2026-10-29. Applicant: Koehrer Medical Engineering GmbH. Device class: 1.

Clearance details

Applicant: Koehrer Medical Engineering GmbH
Product code: Product code NYL
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2026-02-03
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neuss, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NYL

K211721 — PS System2021-12-02
K162436 — EndoVac Pure2016-12-21
K140685 — ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM2014-07-02
K100606 — VATEA ENDONTIC IRRIGATION SYSTEM2010-05-28
K052271 — RINSENDO2006-05-26

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