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Surgyco SEN10230

by Surgyco LLC

Surgyco SEN10230 is a Class II device made by Surgyco LLC, cleared under FDA 510(k) K190502 on 6 Aug 2019 and listed in FDA GUDID since 11 Dec 2025 (UDI-DI 10850053289672), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

510(k) K190502

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850053289672 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190502 Date6 Aug 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190502 decided 6 Aug 2019 Active
  • FDA GUDID UDI-DI 10850053289672 listed 11 Dec 2025 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0850-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0848-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0847-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0849-2024 FDA Class I initiated 28 Dec 2023

    The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Timeline

6 dated events

  1. Cleared FDA 510(k) K190502
  2. Recall initiated FDA recalls Z-0850-2024
  3. Recall initiated FDA recalls Z-0848-2024
  4. Recall initiated FDA recalls Z-0847-2024
  5. Recall initiated FDA recalls Z-0849-2024
  6. Listed FDA GUDID 10850053289672

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgyco
Generic name
General-purpose syringe, single-use
Model / reference
SEN10230
Primary DI / UDI-DI
10850053289672
510(k) Number
FDA product code
PNR
GMDN term
General-purpose syringe, single-use
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K190502)

and 8 more cleared under K190502

Similar devices

Other devices filed under FDA product code PNR (Enteral Syringes With Enteral Specific Connectors).

Other devices from Surgyco LLC

See all devices from Surgyco LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)