BOVIE ULTRASONIC SURGICAL ASPIRATOR— 510(k) K932094

Name: FDA 510(k) clearance K932094
Creator: U.S. Food and Drug Administration
Published: 1993-07-21

Substantially Equivalent

Mdt Corp., Inc.

FDA 510(k) clearance K932094 for BOVIE ULTRASONIC SURGICAL ASPIRATOR, Substantially Equivalent on 1993-07-21. Applicant: Mdt Corp., Inc.. Device class: Unclassified.

Clearance details

Applicant: Mdt Corp., Inc.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1993-04-30
Decision date: 1993-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

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K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE1994-08-10
K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE1994-02-16
K926081 — DENTAL LIGHT1994-01-26

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.