BURS FOR MICRO SURGICAL DRILL SYSTEM— 510(k) K853658

Name: FDA 510(k) clearance K853658
Creator: U.S. Food and Drug Administration
Published: 1985-09-24

Substantially Equivalent

Acumed Instruments Corp.

FDA 510(k) clearance K853658 for BURS FOR MICRO SURGICAL DRILL SYSTEM, Substantially Equivalent on 1985-09-24. Applicant: Acumed Instruments Corp.. Device class: 1.

Clearance details

Applicant: Acumed Instruments Corp.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1985-09-03
Decision date: 1985-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GFF

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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

More clearances from Acumed Instruments Corp.

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K863627 — MICRO SURGICAL DRILL SYSTEM1986-10-02
K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL1985-09-24
K853660 — MICRO SURGICAL DRILL SYSTEM1985-09-24
K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL.1979-12-05
K791399 — ACU-ALERT1979-10-11

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.