Panels › Obstetrics/Gynecology › Product code PBQ · Class 2
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Regulation 884.4530
1510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PBQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Escala Medical | 3 | 0 |
| Coloplast A/S | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| FEMSelect Ltd | 0 | 1 |
| Ibi Israel Biomedical Innovations , Ltd. | 1 | 0 |
| Neomedic International S.L. | 1 | 0 |
| Pop Medical Solutions | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2026 | K260380 | Mendit Escala Medical, Ltd., IL | PBQ |
| Jul 25, 2023 | K230730 | Apyx Escala Medical, IL | PBQ |
| Jun 10, 2022 | K220420 | Saffron Fixation System Coloplast A/S | PBQ |
| Apr 5, 2022 | K213783 | Apyx Escala Medical, IL | PBQ |
| Jul 6, 2016 | K160569 | NeuGuide Pop Medical Solutions, IL | PBQ |
| Jul 29, 2013 | K130059 | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP Ibi Israel Biomedical Innovations , Ltd. | PBQ |
| Oct 12, 2012 | K120831 | ANCHORSURE Neomedic International S.L. | PBQ |
| Dec 22, 2004 | K042603 | GYNECARE PROLENE FASTENER SYSTEM ETHICON, Inc. | PBQ |
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