Zeta Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Zeta Surgical, Inc.” (first 2023, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 142 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2023 | 1 | 182 |
| 2024 | 2 | 44 |
| 2025 | 1 | 109 |
| 2026 | 2 | 114 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zeta Surgical, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| QFF | Electromechanical Arm For A Transcranial Magnetic Stimulation System | 1 | 1 |
| SGE | Extracranial Positional System For A Transcranial Magnetic Stimulation System | 1 | 1 |
Review panels
- Neurology (6)
Most recent Zeta Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261471 | Zeta TMS Navigation System | QFF | 2026-07-09 | 66 |
| K253663 | Zeta Navigation System | HAW | 2026-05-01 | 162 |
| K251927 | Zeta Navigation System (ZNS131-US) | SGE | 2025-10-10 | 109 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | HAW | 2024-10-04 | 57 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | HAW | 2024-01-10 | 30 |
| K230661 | Zeta Cranial Navigation System | HAW | 2023-09-08 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Zeta Surgical, Inc..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Zeta Surgical, Inc. (5)
- Zeta Surgical (1)
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.
- Zeta Development Laboratories (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zeta Surgical, Inc.?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Zeta Surgical, Inc.” (first 2023, latest 2026), across 3 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 Zeta Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zeta Surgical, Inc. is 88 days. Since 2017: 88 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zeta Surgical, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 4); QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System, 1); SGE (Extracranial Positional System For A Transcranial Magnetic Stimulation System, 1).
Next steps
- See all 6 Zeta Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Zeta Surgical, Inc.'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.