Surgi-Vision, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Surgi-Vision, Inc.” (first 1999, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 8 | 8 |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 1 | 1 |
Review panels
Most recent Surgi-Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111073 | SURGIVISION INC. CLEARPOINT SYSTEM | ORR | 2011-06-22 | 65 |
| K020790 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | MOS | 2002-05-21 | 71 |
| K020495 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | MOS | 2002-04-23 | 68 |
| K011781 | INTERCEPT-URETHRAL MICROCOIL | MOS | 2001-08-31 | 85 |
| K003436 | SURGI-VISION GUIDEWIRE COIL | MOS | 2001-02-02 | 88 |
| K002916 | SURGI-VISION PROSTATE COIL | MOS | 2000-11-28 | 70 |
| K002345 | SURGI-VISION URETHRAL COIL | MOS | 2000-10-11 | 70 |
| K994436 | SURGI-VISION ESOPHAGEAL STYLET COIL | MOS | 2000-03-14 | 75 |
| K992193 | ENDO-ESOPHAGEAL MR COIL | MOS | 1999-09-03 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Surgi-Vision, 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 Surgi-Vision, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgi-Vision, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Surgi-Vision, Inc.” (first 1999, latest 2011), across 2 product codes in 2 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 Surgi-Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgi-Vision, Inc. is 70 days.
Which FDA product codes appear under Surgi-Vision, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 8); ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri, 1).
Next steps
- See all 9 Surgi-Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Surgi-Vision, 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.