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Sophysa SP04

by Sophysa SA

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

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 Number03760124138108 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0160-04 FDA Unclassified (pre-2012) initiated 9 Sep 2003 on shared 510(k) K853370
    • Terminated Z-0161-04 FDA Unclassified (pre-2012) initiated 9 Sep 2003 on shared 510(k) K853370

    mislabeled as sterile

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sophysa
Generic Name
Subcutaneous tunneller, single-use
Model / Reference
SP04
Primary DI / UDI-DI
03760124138108
510(k) Number
FDA Product Code
GYK
GMDN Term
Subcutaneous tunneller, single-use
Device Class
Class I
Regulation Number
882.4545
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K853370)

Other devices from Sophysa SA

See all devices from Sophysa SA →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No