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510(k) K940096

PS MEDICAL CATHETER PLACEMENT KIT by Pudenz-Schulte Medical Research Corp. — Product Code GWG

K940096 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL CATHETER PLACEMENT KIT". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code GWG (Endoscope, Neurological), a Class II device regulated under 21 CFR 882.1480. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
January 7, 1994
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 Pudenz-Schulte Medical Research Corp.

  • K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 893 (September 30, 1996)
  • K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER (December 18, 1995)
  • K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT (September 18, 1995)
  • K934167 — IPI DUAL LUMEN PORT (July 14, 1994)
  • K934796 — IPI LOW PROFILE IMPORT (July 14, 1994)
  • K934545 — PS MEDICAL DELTA BURR HOLE VALVE (April 28, 1994)
  • K930206 — PS MEDICAL IPI ACCESS KIT (February 25, 1994)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K913412 — PS MEDICAL CSF-ACCESS DEVICE (March 30, 1993)
  • K922419 — IPI IMPORT (November 20, 1992)

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