SURGICAL BURS— 510(k) K880859

Name: FDA 510(k) clearance K880859
Creator: U.S. Food and Drug Administration
Published: 1988-03-21

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K880859 for SURGICAL BURS, Substantially Equivalent on 1988-03-21. Applicant: New England Surgical Instrument Corp.. Device class: 1.

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-03-01
Decision date: 1988-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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K943758 — SURGICAL BUR1994-08-22
K934583 — BURRS1994-01-26
K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS1989-08-21

More clearances from New England Surgical Instrument Corp.

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K895331 — ELECTROSURGICAL ELECTRODE1989-09-15
K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE1989-09-15
K883963 — RANEY AND LEROY-RANEY SCALP CLIP1988-10-07
K883396 — HANDSWITCHING MONOPOLAR PENCIL1988-09-13
K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-12001988-04-19

Adverse events under product code GFF

product code GFF

Malfunction: 459
Other: 1
Total: 460

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.