PBQ — Fixation, Non-Absorbable Or Absorbable, For Pelvic Use Class II
FDA product code PBQ covers "Fixation, Non-Absorbable Or Absorbable, For Pelvic Use", a Class II medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. Devices under this code are implants. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PBQ
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- Yes
Definition
Attaching suture or stapling ligaments of the pelvic floor.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260380 | escala medical | Mendit | March 4, 2026 |
| K230730 | escala medical | Apyx | July 25, 2023 |
| K220420 | coloplast | Saffron Fixation System | June 10, 2022 |
| K213783 | escala medical | Apyx | April 5, 2022 |
| K160569 | pop medical solutions | NeuGuide | July 6, 2016 |
| K130059 | ibi israel biomedical innovations | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP | July 29, 2013 |
| K120831 | neomedic international s.l | ANCHORSURE | October 12, 2012 |
| K042603 | ethicon | GYNECARE PROLENE FASTENER SYSTEM | December 22, 2004 |