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Phasor 6.35K

by Phasor Health, LLC

Phasor 6.35K 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 20 Feb 2023 (UDI-DI B775635K0), 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 NumberB775635K0 UDI-DI Date20 Feb 2023ListedStatusListed 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 B775635K0 listed 20 Feb 2023 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. Listed FDA GUDID B775635K0
  3. Recall initiated FDA recalls Z-2192-2025

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  • Withdrawn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
Neurosurgical procedure kit, medicated
Model / Ref / Catalog
6.35K
Primary DI / UDI-DI
B775635K0
510(k) Number
FDA product code
HBE
GMDN term
Neurosurgical procedure kit, medicated
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Neurosurgical procedure kit, medicatedSkin stapler/staple, non-bioabsorbableAutomatic cranial perforator, single-use

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
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)