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510(k) K883115

PMT SUBARACHNOID SCREW, MODEL NO.1350-2 by Pmt Corp. — Product Code GWM

K883115 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT SUBARACHNOID SCREW, MODEL NO.1350-2". The FDA issued a decision of Substantially Equivalent on August 29, 1988. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1988
Date Received
July 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

Other clearances by Pmt Corp.

  • K122376 — PMT TRUSCAN SURFACE ELECTRODE (December 19, 2012)
  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K082474 — PMT SUBDURAL CORTICAL ELECTRODES (May 8, 2009)
  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)
  • K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (August 3, 2004)
  • K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND (October 1, 1997)
  • K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (April 29, 1997)
  • K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTR (March 19, 1997)
  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)

Other clearances for product code GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources