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510(k) K883881

MODIFIED MODEL 2001 FIBER OPTICS CATHETER by Metatech Corp. — Product Code GWM

K883881 is an FDA 510(k) premarket notification submitted by Metatech Corp. for the device "MODIFIED MODEL 2001 FIBER OPTICS CATHETER". The FDA issued a decision of Substantially Equivalent on October 27, 1988. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Metatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1988
Date Received
July 29, 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 Metatech Corp.

  • K924314 — MOBILE STANDING FRAME (February 12, 1993)
  • K915370 — COPPER VAPOR LASER SYSTEM (February 7, 1992)
  • K903883 — VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES (September 19, 1990)
  • K890865 — HEXASCAN SCANNER HANDPIECE (March 24, 1989)
  • K883541 — METALASER VASCULASE (November 4, 1988)
  • K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (September 22, 1988)
  • K882552 — METATECH ROBINSON BOLT ACCESSORY (September 8, 1988)
  • K882367 — METATECH MICROCLIP APPLICATOR (August 25, 1988)
  • K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (July 18, 1988)
  • K881447 — METATECH METAL MICROCLIP (June 22, 1988)

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