IRIDIUM 192 WIRES— 510(k) K850163

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K850163 for IRIDIUM 192 WIRES, Substantially Equivalent on 1985-03-26. Applicant: Syncor Intl. Corp.. Device class: 2.

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code IWA
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1985-01-16
Decision date: 1985-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWA

K915253 — IR-192 IMPLANT, MODIFICATION1992-02-27
K894409 — CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD1989-09-29
K874895 — IR-192 IMPLANT1988-02-25
K850382 — IRIDIUM SEEDS1985-08-15
K844248 — IR-192 IMPLANT1985-04-10

More clearances from Syncor Intl. Corp.

K945825 — SECURE SAFETY INSERT1995-04-10
K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C1985-09-19
K850433 — CESIUM 137 ENDOMETRIAL SOURCE1985-08-21
K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-411985-08-21
K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY1985-08-13

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