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510(k) K111073

SURGIVISION INC. CLEARPOINT SYSTEM by Surgi-Vision, Inc. — Product Code ORR

K111073 is an FDA 510(k) premarket notification submitted by Surgi-Vision, Inc. for the device "SURGIVISION INC. CLEARPOINT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 22, 2011. The device falls under product code ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri), a Class II device regulated under 21 CFR 882.4560. Surgi-Vision, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.

Other clearances by Surgi-Vision, Inc.

  • K020790 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCE (May 21, 2002)
  • K020495 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND (April 23, 2002)
  • K011781 — INTERCEPT-URETHRAL MICROCOIL (August 31, 2001)
  • K003436 — SURGI-VISION GUIDEWIRE COIL (February 2, 2001)
  • K002916 — SURGI-VISION PROSTATE COIL (November 28, 2000)
  • K002345 — SURGI-VISION URETHRAL COIL (October 11, 2000)
  • K994436 — SURGI-VISION ESOPHAGEAL STYLET COIL (March 14, 2000)
  • K992193 — ENDO-ESOPHAGEAL MR COIL (September 3, 1999)

Other clearances for product code ORR

  • K181195 — ClearPoint System (November 2, 2018)
  • K171257 — ClearPoint System (October 20, 2017)
  • K100836 — CLEARPOINT SYSTEM (June 16, 2010)

FDA data resources