BIOPSY KIT— 510(k) K892389

Unknown

I M, Inc.

FDA 510(k) clearance K892389 for BIOPSY KIT, Unknown on 1989-07-17. Applicant: I M, Inc..

Clearance details

Applicant: I M, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1989-04-07
Decision date: 1989-07-17
Decision: Unknown
Clearance type: Traditional
Location: Fairfield, NJ, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.