510(k) K153267
- Device
- ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
- Applicant
- ORIGIO A/S
- 510(k) number
- K153267
- Product code
- MQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-22
- Date received
- 2015-11-12
- Regulation
- 884.6180
- Classification name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Tove Kjaer
- Address
- Knardrupvej 2 Måløv DK 2760 2760
FDA Registration Numbers
- 3007800906
- 3004048494
- 3030681110
- 1221433
- 2022379
- 3025773437
- 3014755376
- 3003995932
- 3014295858
- 3021166069
- 3036725842
- 3003766921
- 3008876063
- 2031824
- 3005580113
- 3004882774
- 3003272500
- 3016126174
- 1216677
- 3007738736
- 3017896194
- 3018010054
- 3010413864
- 3033813683
- 3030390242
- 1222779
- 9616005
- 3003274090
- 3012853704
- 3015140190
- 3036495174
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 60888937029798 | ORIGIO Gradient 90 w/o Gentamicin | Coopersurgical, Inc. | 2026-03-12 |
| 60888937029415 | ORIGIO Gradient 40/80 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029330 | ORIGIO Sperm Wash | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029361 | ORIGIO Gradient 100 | Coopersurgical, Inc. | 2026-02-05 |
| 00888937029383 | ORIGIO Gradient 90 | Coopersurgical, Inc. | 2026-02-05 |
| 00888937030396 | ORIGIO Sperm Wash | Coopersurgical, Inc. | 2026-02-05 |
| 00888937030419 | ORIGIO Gradient 100 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029392 | ORIGIO Gradient 40/80 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029408 | ORIGIO Gradient 40/80 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937816886 | ORIGIO Gradient 40/80 | Origio A/S | 2018-04-18 |
| 00888937816822 | ORIGIO Gradient 100 | Origio A/S | 2018-04-18 |
| 00888937816853 | ORIGIO Gradient 90 | Origio A/S | 2018-04-18 |
| 00888937816891 | ORIGIO Sperm Wash | Origio A/S | 2018-04-18 |
| 20888937816840 | ORIGIO Gradient 100 | Origio A/S | 2018-04-18 |
| 20888937816901 | ORIGIO Sperm Wash | Origio A/S | 2018-04-18 |
| 60888937816862 | ORIGIO Gradient 40/80 | Origio A/S | 2018-04-18 |
| 60888937816879 | ORIGIO Gradient 40/80 | Origio A/S | 2018-04-18 |
Legacy Summary
summary
FDA Review
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