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Virtus Virtus with Strap Kit C

by Somnomed Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K261366

FDA submission, from GUDID

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 Number00851826007373 UDI-DI Date17 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK261366 Date12 Jun 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Virtus
Generic name
Mandible-repositioning sleep-disordered breathing orthosis
Model / reference
Virtus with Strap Kit C
Primary DI / UDI-DI
00851826007373
510(k) Number
FDA product code
LRK
GMDN term
Mandible-repositioning sleep-disordered breathing orthosis
Device class
Class II
Regulation number
872.5570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261366)

Other devices from Somnomed Inc.

See all devices from Somnomed Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No