ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Media, Reproductive

ORIGIO A/S

The following data is part of a premarket notification filed by Origio A/s with the FDA for Origio Gradient 100, Origio Gradient 90, Origio Gradient 40/80, Origio Sperm Wash.

Pre-market Notification Details

• Device ID: K153267
• 510k Number: K153267
• Device Name: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
• Classification: Media, Reproductive
• Applicant: ORIGIO A/S KNARDRUPVEJ 2 Malov, DK 2760
• Contact: Tove Kjaer
• Correspondent: Tove Kjaer; ORIGIO A/S KNARDRUPVEJ 2 Malov, DK 2760
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-12
• Decision Date: 2016-07-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
60888937816886	K153267	000
60888937029361	K153267	000
00888937029383	K153267	000
00888937030396	K153267	000
00888937030419	K153267	000
60888937029392	K153267	000
60888937029408	K153267	000
60888937029415	K153267	000
00888937816822	K153267	000
00888937816853	K153267	000
00888937816891	K153267	000
20888937816840	K153267	000
20888937816901	K153267	000
60888937816862	K153267	000
60888937816879	K153267	000
60888937029330	K153267	000