NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER— 510(k) K852402

Name: FDA 510(k) clearance K852402
Creator: U.S. Food and Drug Administration
Published: 1985-07-11

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K852402 for NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER, Substantially Equivalent on 1985-07-11. Applicant: North American Instrument Corp.. Device class: 1.

Clearance details

Applicant: North American Instrument Corp.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-06-06
Decision date: 1985-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: NY, US

Download summary PDF View on FDA.gov ↗

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K862564 — A.C.L. GUIDE KIT1986-08-18
K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY1985-12-24

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K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS1993-03-03
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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.