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510(k) K952832

DISPOSABLE BIPOLAR ELECTRODE by Neuro Navigational Corp. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1995
Date Received
June 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Neuro Navigational Corp.

  • K965078 — 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS (March 6, 1997)
  • K961406 — NEUROVIEW SCISSORS (June 13, 1996)
  • K961300 — ASPIRATION/IRRIGATION CATHETER (June 7, 1996)
  • K961173 — 1.2MM REUSABLE NEUROVIEW ENDOSCOPE (June 7, 1996)
  • K960792 — DISPOSABLE NEUROVIEW INTRODUCER SHEATH (April 11, 1996)
  • K954938 — DISPOSABLE NEUROVIEW OPERATING SHEATH (March 7, 1996)
  • K955351 — NEUROVIEW COAXIAL BIPOLAR ELECTRODE (February 29, 1996)
  • K954899 — RIGID NEUROVIEW ENDOSCOPE (December 19, 1995)
  • K955467 — NEUROVIEW COAXIAL BIPOLAR ELECTRODE (December 18, 1995)
  • K955037 — RIGID NEUROVIEW ENDOSCOPE (December 4, 1995)

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