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Sophysa Pso-Vtt

by Sophysa SA 2 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K162108

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760409447093 UDI-DI Date8 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162108 Date17 Apr 2017DecidedStatusActive

Official records

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-1029-2026 FDA Class II initiated 17 Nov 2025

    Customer complaints of Pressio monitor rebooting.

  • 2 recalls, same reason

    • Ongoing Z-1825-2024 FDA Class II initiated 9 Apr 2024
    • Ongoing Z-1826-2024 FDA Class II initiated 9 Apr 2024

    An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sophysa
Generic name
Intracerebral sensor catheter, short-term
Model / reference
PSO-VTT
Primary DI / UDI-DI
03760409447093
510(k) Number
FDA product code
GWM
GMDN term
Intracerebral sensor catheter, short-term
Device class
Class II
Regulation number
882.1620
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K162108)

Other devices from Sophysa SA

See all devices from Sophysa SA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (9)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No