Myriad SPECTRA Light Source— 510(k) K232567

Substantially Equivalent

Nico Corporation

FDA 510(k) clearance K232567 for Myriad SPECTRA Light Source, Substantially Equivalent on 2024-03-14. Applicant: Nico Corporation. Device class: 2.

Clearance details

Applicant: Nico Corporation
Product code: Code QFX
Device class: Class 2
Regulation: 21 CFR 882.4950
Advisory panel: Neurology
Date received: 2023-08-24
Decision date: 2024-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFX

K251286 — Affirm 4002026-01-21
K240215 — BLUE 400; BLUE 400 S2024-06-28
K211346 — BLUE 4002022-07-22
DEN180024 — Leica FL4002019-03-28

More clearances from Nico Corporation

Recalls naming K232567

K-number listed on FDA's recall record

Z-0600-2026 — NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/FiberClass II·Ongoing·Stryker Corporation·20251031

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232567.

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