Advanced Neuromodulation Systems: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Advanced Neuromodulation Systems” (first 1999, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 41 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 24 | 24 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 1 | 1 |
Review panels
- Neurology (25)
Most recent Advanced Neuromodulation Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | GZB | 2009-12-23 | 140 |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | GZB | 2009-06-02 | 62 |
| K081208 | CINCH ANCHOR, MODEL 1194 | GZB | 2008-07-18 | 80 |
| K072462 | WIDE SPACED QUATTRODE LEADS | GZB | 2007-10-11 | 41 |
| K070847 | TRIAL CABLE, 3009 | GZB | 2007-04-11 | 14 |
| K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | GZB | 2006-12-12 | 63 |
| K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | GZB | 2005-12-15 | 24 |
| K052374 | RAPID PROGEAMMER 3.0 | GZB | 2005-11-22 | 84 |
| K052418 | AXXESS BUTTERFLY ANCHOR | GZB | 2005-09-26 | 24 |
| K050922 | ANS SCS ACCESSORY KIT | GZB | 2005-05-18 | 35 |
15 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2012-09-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Medical Solutions, Ltd. (22 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Neuromodulation Systems?
FDA lists 25 510(k) clearances under the applicant name “Advanced Neuromodulation Systems” (first 1999, latest 2009), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Neuromodulation Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Neuromodulation Systems is 41 days.
Which FDA product codes appear under Advanced Neuromodulation Systems?
The most frequent FDA product codes under this applicant name are GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 24); GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief), 1).
Next steps
- See all 25 Advanced Neuromodulation Systems clearances with predicates and recalls
- Run predicate analysis for product code GZB, Advanced Neuromodulation Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.