Surgical Navigation Technologies, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Surgical Navigation Technologies, Inc.” (first 1996, latest 2000), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 87 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 | 15 | 15 |
| IYE | Accelerator, Linear, Medical | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| HRX | Arthroscope | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Neurology (15)
- Radiology (11)
- Orthopedic (1)
Most recent Surgical Navigation Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM | IYE | 2000-10-20 | 267 |
| K994355 | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION | IYE | 2000-03-22 | 90 |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | HAW | 2000-02-22 | 214 |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | HAW | 1999-12-29 | 120 |
| K993021 | METRX SYSTEM | HRX | 1999-11-10 | 63 |
| K992354 | SNT IMAGE ANALYSIS SYSTEM | LLZ | 1999-10-12 | 90 |
| K991468 | IMMERGE IMAGE CORRELATION | LLZ | 1999-07-06 | 70 |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | HAW | 1999-04-22 | 90 |
| K983670 | STEALTHSTATION SYSTEM | HAW | 1999-01-14 | 87 |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | LMD | 1999-01-12 | 63 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgical Navigation Technologies, 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.
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.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Navigation Technologies, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Surgical Navigation Technologies, Inc.” (first 1996, latest 2000), across 5 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 Surgical Navigation Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Navigation Technologies, Inc. is 87 days.
Which FDA product codes appear under Surgical Navigation Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 15); IYE (Accelerator, Linear, Medical, 7); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 27 Surgical Navigation Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Surgical Navigation Technologies, 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.