Phasor Drill— 510(k) K161704

Name: FDA 510(k) clearance K161704
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Substantially Equivalent

Biotex, Inc.

FDA 510(k) clearance K161704 for Phasor Drill, Substantially Equivalent on 2016-12-01. Applicant: Biotex, Inc.. Device class: 2.

Clearance details

Applicant: Biotex, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2016-06-20
Decision date: 2016-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBE

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K253627 — Surgify Halo (11 models)2026-03-26
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K252060 — GREEN2025-10-31
K252662 — UniBur2025-09-19
K251433 — Surgify Halo (8 models)2025-06-04

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K081656 — VISUALASE THERMAL THERAPY SYSTEM2008-09-10

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K161704

K-number listed on FDA's recall record

Z-2192-2025 — Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35Class II·Ongoing·Phasor Health, LLC·20250321

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161704.

Data sourced from openFDA. This site is unofficial and independent of the FDA.