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Phoenix Neuro SR12

by Sophysa

Phoenix Neuro SR12 is a Class II device made by Sophysa, cleared under FDA 510(k) K853362 on 3 Sep 1985 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760124134896), active as of 12 Nov 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K853362

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760124134896 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853362 Date3 Sep 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K853362 decided 3 Sep 1985 Active
  • FDA GUDID UDI-DI 03760124134896 listed 16 Oct 2015 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0367-06 FDA Unclassified (pre-2012) initiated 24 Mar 2005 on shared 510(k) K853362
    • Terminated Z-0365-06 FDA Unclassified (pre-2012) initiated 24 Mar 2005 on shared 510(k) K853362
    • Terminated Z-0366-06 FDA Unclassified (pre-2012) initiated 24 Mar 2005 on shared 510(k) K853362

    stylet in package is shorter than that claimed on the label

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K853362
  2. Recall initiated FDA recalls Z-0367-06
  3. Recall initiated FDA recalls Z-0365-06
  4. Recall initiated FDA recalls Z-0366-06
  5. Listed FDA GUDID 03760124134896

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phoenix Neuro
Generic name
Intracerebral infusion/drainage catheter, long-term
Model / reference
SR12
Primary DI / UDI-DI
03760124134896
510(k) Number
FDA product code
JXG
GMDN term
Intracerebral infusion/drainage catheter, long-term
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Intracerebral infusion/drainage catheter, long-term

Cleared under the same submission (K853362)

and 8 more cleared under K853362

Similar devices in this category

Other devices filed under Intracerebral infusion/drainage catheter, long-term.

Other devices from Sophysa

See all devices from Sophysa →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)