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Catheter Extension Cable PSO-EC30

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 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03701813000054 UDI-DI Date27 Oct 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  • Withdrawn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
Catheter Extension Cable
Generic name
Electrical-only medical device connection cable, reusable
Model / reference
PSO-EC30
Primary DI / UDI-DI
03701813000054
510(k) Number
FDA product code
GWM
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
882.1620
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K162108)

Other devices from Sophysa SA

See all devices from Sophysa SA →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No