MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES— 510(k) K900388

Name: FDA 510(k) clearance K900388
Creator: U.S. Food and Drug Administration
Published: 1990-05-07

Substantially Equivalent

Midas Rex Pneumatic Tools, Inc.

FDA 510(k) clearance K900388 for MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES, Substantially Equivalent on 1990-05-07. Applicant: Midas Rex Pneumatic Tools, Inc.. Device class: 2.

Clearance details

Applicant: Midas Rex Pneumatic Tools, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 1990-01-29
Decision date: 1990-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Midas Rex Pneumatic Tools, Inc.

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K972289 — MIDAS REX MOTOR1997-09-12
K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)1997-04-09
K962483 — MIDAS REX III MOTOR1996-11-19
K953434 — MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)1996-05-16
K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS1995-10-18

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 →

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