SURGICAL BUR— 510(k) K872475

Substantially Equivalent

Tava Surgical Instruments

FDA 510(k) clearance K872475 for SURGICAL BUR, Substantially Equivalent on 1987-07-02. Applicant: Tava Surgical Instruments. Device class: 1.

Clearance details

Applicant
Tava Surgical Instruments
Product code
Code GFF
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Van Nuys, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GFF

product code GFF
Malfunction
459
Other
1
Total
460

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K872475

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K872475.

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