DeviceClearance

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash— 510(k) K153267

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K153267 for ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash, Substantially Equivalent on 2016-07-22. Applicant: Origio A/S. Device class: 2.

Clearance details

Applicant
Origio A/S
Product code
Code MQL
Device class
Class 2
Regulation
21 CFR 884.6180
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Måløv, DK
Download summary PDFView on FDA.gov ↗

Recent devices under product code MQL

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More clearances from Origio A/S

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Recalls naming K153267

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153267.

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