V. Mueller Neuro/Spine: FDA clearances and approvals
V. Mueller Neuro/Spine has 8 FDA 510(k) clearances (first 1994, latest 2000), across 7 product codes in 2 review panels. Median 510(k) review time: 168 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HCH | Clip, Aneurysm | 2 | 2 |
| FZP | Clip, Implantable | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HAE | Rongeur, Manual | 1 | 1 |
| HBA | Neurosurgical Paddie | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
Review panels
Most recent V. Mueller Neuro/Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002276 | PSI SKULL CLAMP | HBL | 2000-08-29 | 34 |
| K993019 | PACIFIC SURGICAL PATTIES | HBA | 2000-03-30 | 204 |
| K991959 | PSI TITANIUM ANEURYSM CLIP | HCH | 2000-01-06 | 210 |
| K991002 | PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP | FZP | 1999-06-11 | 78 |
| K972750 | TAKA ANEURYSM CLIP | HCH | 1998-07-09 | 351 |
| K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | GZT | 1997-01-23 | 80 |
| K942601 | PSI FLEXIBLE ARM | GCJ | 1994-12-27 | 209 |
| K943635 | ULTRA-LINE RONGEUR | HAE | 1994-12-07 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named V. Mueller Neuro/Spine.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does V. Mueller Neuro/Spine have?
V. Mueller Neuro/Spine has 8 FDA 510(k) clearances (first 1994, latest 2000), across 7 product codes in 2 review panels.
How long does FDA take to clear V. Mueller Neuro/Spine's 510(k)s?
The median time from FDA receipt to decision across V. Mueller Neuro/Spine's cleared 510(k)s is 168 days.
What devices does V. Mueller Neuro/Spine make?
Its most frequent FDA product codes are HCH (Clip, Aneurysm, 2); FZP (Clip, Implantable, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Has V. Mueller Neuro/Spine had device recalls?
openFDA lists no recalls under a recalling firm name matching V. Mueller Neuro/Spine. Related entities may recall under other names.
Next steps
- See all 8 V. Mueller Neuro/Spine clearances with predicates and recalls
- Run predicate analysis for product code HCH, V. Mueller Neuro/Spine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.