Stereotactic Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stereotactic Medical Systems, Inc.” (first 1986, latest 1989), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| FPD | Tube, Feeding | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
Review panels
Most recent Stereotactic Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896156 | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM | GZT | 1989-12-06 | 43 |
| K884415 | EP-100 (SERIES) | FPD | 1989-02-28 | 131 |
| K883653 | EP-100 INFUSION PUMP | FRN | 1988-11-01 | 67 |
| K871046 | COMPASS STEREOTACTIC POSITIONING SYSTEM | HAW | 1987-05-08 | 52 |
| K862220 | COMPASS CT STEREOTACTIC ADAPTATION SYSTEM | HAW | 1986-06-18 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Stereotactic Medical Systems, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Stereotactic Medical Systems, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Stereotactic Image Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stereotactic Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Stereotactic Medical Systems, Inc.” (first 1986, latest 1989), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stereotactic Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stereotactic Medical Systems, Inc. is 52 days.
Which FDA product codes appear under Stereotactic Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 2); FPD (Tube, Feeding, 1); FRN (Pump, Infusion, 1).
Next steps
- See all 5 Stereotactic Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Stereotactic Medical Systems, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.