Home / 510(k) Clearances / K960915

510(k) K960915

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX by Clarus Medical Systems, Inc. — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1996
Date Received
March 6, 1996
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 Clarus Medical Systems, Inc.

  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K974579 — PERCSCOPE MODEL 2600 (February 18, 1998)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K971455 — CLARUS MODEL 5197 SIGHTLITE (May 20, 1997)
  • K962255 — CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) (September 11, 1996)
  • K955598 — CLARUS SPINEPEN MODEL 2126 (February 6, 1996)
  • K953685 — INSTRUMENT SCOPE (October 12, 1995)
  • K945633 — NEURO CHANNEL ENDOSCOPE MODEL 2232 (September 19, 1995)
  • K945296 — CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 (July 14, 1995)
  • K941188 — CLARUS NEURO ENDOSCOPE (MODEL 2230) (April 25, 1995)

Other clearances for product code GWG

  • 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)
  • K211202 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Preci (August 6, 2021)
  • K210251 — ClearPath Disposable Introducer (April 2, 2021)