SURGICAL BURS— 510(k) K880706

Name: FDA 510(k) clearance K880706
Creator: U.S. Food and Drug Administration
Published: 1988-02-26

Substantially Equivalent

Nuell Air Equipment & Hospital Supplies, Inc.

FDA 510(k) clearance K880706 for SURGICAL BURS, Substantially Equivalent on 1988-02-26. Applicant: Nuell Air Equipment & Hospital Supplies, Inc.. Device class: 1.

Clearance details

Applicant: Nuell Air Equipment & Hospital Supplies, Inc.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-02-22
Decision date: 1988-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K974025 — ANSPACH SHIELDED ATTACHMENT1998-07-06
K950449 — SURGICAL BUR1995-03-01
K943758 — SURGICAL BUR1994-08-22
K934583 — BURRS1994-01-26
K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS1989-08-21

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K881418 — CRANIOTOME BLADE OR NEURO BLADE1988-05-31
K880601 — WIRE PASS DRILL BITS1988-05-06

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.