Surgi-Vision, Inc.
Columbia, MD, US
Surgi-Vision, Inc. appears in FDA device records in Columbia, MD. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Surgi-Vision, Inc. between 1999 and 2011. The busiest year on record is 2000, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111073 | SURGIVISION INC. CLEARPOINT SYSTEM | ORR | Substantially Equivalent | |
| K020790 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | MOS | Substantially Equivalent | |
| K020495 | INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL | MOS | Substantially Equivalent | |
| K011781 | INTERCEPT-URETHRAL MICROCOIL | MOS | Substantially Equivalent | |
| K003436 | SURGI-VISION GUIDEWIRE COIL | MOS | Substantially Equivalent | |
| K002916 | SURGI-VISION PROSTATE COIL | MOS | Substantially Equivalent | |
| K002345 | SURGI-VISION URETHRAL COIL | MOS | Substantially Equivalent | |
| K994436 | SURGI-VISION ESOPHAGEAL STYLET COIL | MOS | Substantially Equivalent | |
| K992193 | ENDO-ESOPHAGEAL MR COIL | MOS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain