BIOPSY NEEDLE GUIDE KIT, STERILE— 510(k) K871503

Name: FDA 510(k) clearance K871503
Creator: U.S. Food and Drug Administration
Published: 1987-07-10

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K871503 for BIOPSY NEEDLE GUIDE KIT, STERILE, Substantially Equivalent on 1987-07-10. Applicant: Amedic USA. Device class: 1.

Clearance details

Applicant: Amedic USA
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-04-17
Decision date: 1987-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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
K862564 — A.C.L. GUIDE KIT1986-08-18
K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY1985-12-24
K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER1985-07-11

More clearances from Amedic USA

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K897120 — EQUIP COVERS, STERILE1990-01-04
K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE1989-09-05
K892069 — EXTENDED COVERS, STERILE1989-08-08
K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE1989-08-08
K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE1989-08-04

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.