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Phasor 6.35

by Phasor Health, LLC

Phasor 6.35 is an automatic cranial perforator (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) 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 B7756350), 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 NumberB7756350 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 B7756350 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 B7756350
  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  • Withdrawn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
Automatic cranial perforator, single-use
Model / Ref / Catalog
6.35
Primary DI / UDI-DI
B7756350
510(k) Number
FDA product code
HBE
GMDN term
Automatic cranial perforator, single-use
Device class
Class II
Regulation number
882.4310
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Automatic cranial perforator, single-use

Cleared under the same submission (K161704)

and 8 more cleared under K161704

Similar devices in this category

Other devices filed under Automatic cranial perforator, single-use.

Other devices from Phasor Health, LLC

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    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)