DRILL GUIDE— 510(k) K841619

Name: FDA 510(k) clearance K841619
Creator: U.S. Food and Drug Administration
Published: 1984-07-11

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841619 for DRILL GUIDE, Substantially Equivalent on 1984-07-11. Applicant: Plastafil, Inc.. Device class: 1.

Clearance details

Applicant: Plastafil, Inc.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-04-19
Decision date: 1984-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZX

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K914715 — PARALLELING GUIDES1994-02-16
K871413 — CIVCO STEPPER1987-07-14
K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE1987-07-10
K862564 — A.C.L. GUIDE KIT1986-08-18
K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY1985-12-24

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.