FDA product code PBQ: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
PBQ is the FDA product code for fixation, non-absorbable or absorbable, for pelvic use. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 8 510(k) submissions under PBQ, 4 in the last five years, from 7 different applicants. The average 510(k) review took 128 days (median 126); 27 days on average over the last three years. FDA has posted 1 recall for PBQ devices, 1 initiated in the last five years.
Definition
Attaching suture or stapling ligaments of the pelvic floor.
Classification
| Field | Value |
|---|---|
| Device name | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PBQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 120 |
| 2023 | 1 | 131 |
| 2026 | 1 | 27 |
Compare with all 510(k) review times · Search every PBQ clearance
Top PBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Escala Medical | 2 | 2023-07-25 |
| Escala Medical, Ltd. | 1 | 2026-03-04 |
| Coloplast A/S | 1 | 2022-06-10 |
| Pop Medical Solutions | 1 | 2016-07-06 |
| Ibi Israel Biomedical Innovations , Ltd. | 1 | 2013-07-29 |
2 more applicants have PBQ clearances. See the full list in Caduvo.
Most recent PBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260380 | Escala Medical, Ltd. | Mendit | 2026-03-04 | 27 |
| K230730 | Escala Medical | Apyx | 2023-07-25 | 131 |
| K220420 | Coloplast A/S | Saffron Fixation System | 2022-06-10 | 116 |
| K213783 | Escala Medical | Apyx | 2022-04-05 | 123 |
| K160569 | Pop Medical Solutions | NeuGuide | 2016-07-06 | 128 |
Recalls for PBQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-12-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J0881 — Injection, darbepoetin alfa, 1 microgram (non-esrd use)
- J0888 — Injection, epoetin beta, 1 microgram, (for non esrd use)
Frequently asked questions
What is FDA product code PBQ?
PBQ is the FDA product code for fixation, non-absorbable or absorbable, for pelvic use. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is PBQ?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBQ?
Across 8 cleared submissions the average was 128 days from receipt to decision (median 126).
Which companies have the most PBQ clearances?
Escala Medical (2); Escala Medical, Ltd. (1); Coloplast A/S (1); Pop Medical Solutions (1); Ibi Israel Biomedical Innovations , Ltd. (1).
Have PBQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PBQ
- Run a recall and safety report across every PBQ manufacturer
- Watch product code PBQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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