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Versius Insulating Sleeve Accessory 10021

by Cmr Surgical Limited GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060548211318 UDI-DIDate9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

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.

Specification

GUDID

Trade Name
Versius Insulating Sleeve Accessory
Generic Name
Electrosurgical system monitor/shield
Model / Reference
10021
Primary DI / UDI-DI
05060548211318
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

See all devices from Cmr Surgical Limited →

Properties

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

Other properties (10)

  • Single Use: No
  • 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