KLS Martin Neuro Rongeurs— 510(k) K210741

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K210741 for KLS Martin Neuro Rongeurs, Substantially Equivalent on 2022-06-03. Applicant: KLS-Martin L.P.. Device class: 2.

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2021-03-12
Decision date: 2022-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAE

K242759 — Geister K-Rex rongeurs2025-06-06
K223596 — SQ.line KERRISON2023-06-29
K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur2023-03-03
K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur2022-10-07
K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur2021-05-04

More clearances from KLS-Martin L.P.

K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more2026-08-17
K253660 — KLS Martin Pure Pectus System2026-02-20
K254162 — KLS Martin Ixos System2026-02-20
K250988 — KLS Martin Pure Pectus System2025-12-11
K250865 — KLS Martin IPS Forearm System2025-11-14

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