510(k) K003914

MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES by Medtronic PS Medical — Product Code GWG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 22, 2001
Date Received: December 19, 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)
K002572 — MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003 (November 16, 2000)
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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