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Phasor 8.40l

by Phasor Health, LLC

Phasor 8.40l is a Class II device made by Phasor Health, LLC, cleared under FDA 510(k) K161704 on 1 Dec 2016 and listed in FDA GUDID since 27 Mar 2026 (UDI-DI B775840L0), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

510(k) K161704

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 NumberB775840L0 UDI-DI Date27 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161704 Date1 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161704 decided 1 Dec 2016 Active
  • FDA GUDID UDI-DI B775840L0 listed 27 Mar 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2192-2025 FDA Class II initiated 21 Mar 2025

    Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

Timeline

3 dated events

  1. Cleared FDA 510(k) K161704
  2. Recall initiated FDA recalls Z-2192-2025
  3. Listed FDA GUDID B775840L0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phasor
Generic name
Cranial trephine, single-use
Model / reference
8.40L
Primary DI / UDI-DI
B775840L0
510(k) Number
FDA product code
HBE
GMDN term
Cranial trephine, single-use
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K161704)

and 8 more cleared under K161704

Other devices from Phasor Health, LLC

  • Phasor 11.0l Open recall

    Class II

  • Phasor 11.0S Open recall

    Class II

  • Phasor 14.0S Open recall

    Class II

  • Phasor 14.0l Open recall

    Class II

See all devices from Phasor Health, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)