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510(k) K990333

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 by Medtronic PS Medical — Product Code GWG

K990333 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015". The FDA issued a decision of Substantially Equivalent on April 28, 1999. The device falls under product code GWG (Endoscope, Neurological), a Class II device regulated under 21 CFR 882.1480. Medtronic PS Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1999
Date Received
February 3, 1999
Clearance Type
Traditional
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)
  • 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)
  • 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)

Other clearances for product code GWG

  • K253602 — Precision S 4K Sinuscope (June 4, 2026)
  • K253679 — Hydro Irrigation System (May 8, 2026)
  • K243429 — HJY VisualNext 3D Endoscopic Vision System (May 21, 2025)
  • K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (April 9, 2025)
  • K233391 — cCeLL - In vivo (August 21, 2024)
  • K223615 — Digital ClarusScope System, Digital NeuroPEN System (November 21, 2023)
  • K232618 — Aurora Surgiscope System (October 27, 2023)
  • K230125 — Neuroblade System (October 13, 2023)
  • K232159 — QEVO System (September 21, 2023)
  • K222735 — HJY VisualNext Endoscopic Vision System (July 28, 2023)

FDA data resources