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510(k) K994436

SURGI-VISION ESOPHAGEAL STYLET COIL by Surgi-Vision, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2000
Date Received
December 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Surgi-Vision, Inc.

  • K111073 — SURGIVISION INC. CLEARPOINT SYSTEM (June 22, 2011)
  • 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)
  • K992193 — ENDO-ESOPHAGEAL MR COIL (September 3, 1999)

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  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)
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  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)
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  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
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