510(k) K220420
- Device
- Saffron Fixation System
- Applicant
- Coloplast A/S
- 510(k) number
- K220420
- Product code
- PBQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-10
- Date received
- 2022-02-14
- Regulation
- 884.4530
- Classification name
- Fixation, Non-absorbable Or Absorbable, For Pelvic Use
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gayatri Ghadge
- Address
- 1601 W. River Rd. N. Plymouth MN US 55411 55411
FDA Registration Numbers#
- 2125050
- 3015192261
- 2183744
- 3024820202
- 3008729892
- 3010892271
- 3004838863
- 3006621295
- 3004612223
Source Documents#
Other 510(k) Records For Product Code PBQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260380 | Mendit | Escala Medical, Ltd. | 2026-03-04 |
| K230730 | Apyx | Escala Medical | 2023-07-25 |
| K213783 | Apyx | Escala Medical | 2022-04-05 |
| K160569 | NeuGuide | Pop Medical Solutions | 2016-07-06 |
| K130059 | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP | Ibi Israel Biomedical Innovations , Ltd. | 2013-07-29 |
| K120831 | ANCHORSURE | Neomedic International S.L. | 2012-10-12 |
| K042603 | GYNECARE PROLENE FASTENER SYSTEM | ETHICON, Inc. | 2004-12-22 |
Legacy Summary#
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FDA Review#
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