SURGIVISION INC. CLEARPOINT SYSTEM— 510(k) K111073
Substantially EquivalentSurgi-Vision, Inc.
FDA 510(k) clearance K111073 for SURGIVISION INC. CLEARPOINT SYSTEM, Substantially Equivalent on 2011-06-22. Applicant: Surgi-Vision, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgi-Vision, Inc.
- Product code
- Code ORR
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code ORR
view allMore clearances from Surgi-Vision, Inc.
view all- K020790 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
- K020495 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
- K011781 — INTERCEPT-URETHRAL MICROCOIL
- K003436 — SURGI-VISION GUIDEWIRE COIL
- K002916 — SURGI-VISION PROSTATE COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.