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510(k) K002572

MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 by Medtronic PS Medical — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2000
Date Received
August 18, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Neurological
Device Class
Class II
Regulation Number
882.1480
Review Panel
NE
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Medtronic PS Medical

  • K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 (February 11, 2002)
  • K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (May 7, 2001)
  • K010487 — BIPOLAR PENCIL, MODEL 3901-002, 3900-002 (May 3, 2001)
  • K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2 (April 20, 2001)
  • K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (February 22, 2001)
  • K991502 — MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 (September 12, 2000)
  • K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3 (April 28, 1999)
  • K984053 — BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (February 4, 1999)
  • K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAG (January 26, 1999)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)

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