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Versius Insulating Sleeve Accessory – Carton Pack (Qty 12 x 10021), 10022

by Cmr Surgical Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060548211349 UDI-DI Date18 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2717-2026 FDA Class II initiated 9 Jun 2026

    Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Electrosurgical system monitor/shield
Model / Reference
10022
Primary DI / UDI-DI
05060548211349
510(k) Number
FDA Product Code
SCV
GMDN Term
Electrosurgical system monitor/shield
Device Class
Class II
Regulation Number
878.4964
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252111)

Show all (12)

Other devices from Cmr Surgical Limited

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No