BASIC BIOPSY TRAY. DISPOSABLE, STERILE— 510(k) K964921

Name: FDA 510(k) clearance K964921
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Trinity Laboratories, Inc.

FDA 510(k) clearance K964921 for BASIC BIOPSY TRAY. DISPOSABLE, STERILE, Substantially Equivalent on 1997-01-22. Applicant: Trinity Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1996-12-09
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salisbury, MD, US

Download summary PDF View on FDA.gov ↗

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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.