SUCTION TIP— 510(k) K893667

Substantially Equivalent

Thomson & Shelton Instrumentation Co, Inc.

FDA 510(k) clearance K893667 for SUCTION TIP, Substantially Equivalent on 1989-08-21. Applicant: Thomson & Shelton Instrumentation Co, Inc..

Clearance details

Applicant: Thomson & Shelton Instrumentation Co, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1989-05-15
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockwall, TX, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.