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Silex EZL-1001-45

by Silex Medical, LLC

Silex EZL-1001-45 is a Class II device made by Silex Medical, LLC, cleared under FDA 510(k) K946263 on 26 Jan 1995 (2 earlier submissions) and listed in FDA GUDID since 19 Feb 2018 (UDI-DI B331EZL100145), active as of 23 Oct 2026. 8 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

8 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB331EZL100145 UDI-DI Date19 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946263 Date26 Jan 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946263 decided 26 Jan 1995 Active· +2 more in the status table
  • FDA GUDID UDI-DI B331EZL100145 listed 19 Feb 2018 Listed

Recalls

8 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-1899-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1894-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1900-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1898-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1897-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1896-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1895-2025 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1893-2025 FDA Class II initiated 9 Jan 2024

    Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Timeline

12 dated events

  1. Cleared FDA 510(k) K946263
  2. Listed FDA GUDID B331EZL100145
  3. Recall initiated FDA recalls Z-1899-2025
  4. Recall initiated FDA recalls Z-1894-2025
  5. Recall initiated FDA recalls Z-1900-2025
  6. Recall initiated FDA recalls Z-1898-2025
  7. Recall initiated FDA recalls Z-1897-2025
  8. Recall initiated FDA recalls Z-1896-2025
  9. Recall initiated FDA recalls Z-1895-2025
  10. Recall initiated FDA recalls Z-1893-2025

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Silex
Generic name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Model / reference
EZL-1001-45
Primary DI / UDI-DI
B331EZL100145
510(k) Number
FDA product code
GEI, GCJ
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device class
Class II
Regulation number
878.4400, 876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid endoscopic tissue manipulation forceps, reusableEndoscopic electrosurgical handpiece/electrode, monopolar, reusable

Cleared under the same submission (K914910)

and 8 more cleared under K914910

Cleared under the same submission (K933387)

and 8 more cleared under K933387

Other devices from Silex Medical, LLC

  • Signature 5851071 Open recall

    Class II

  • Silex EZL-1063 Open recall

    Class II

  • Signature 5851050 Open recall

    Class II

  • Signature 5851053 Open recall

    Class II

See all devices from Silex Medical, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)