CIVCO STEPPER— 510(k) K871413

Name: FDA 510(k) clearance K871413
Creator: U.S. Food and Drug Administration
Published: 1987-07-14

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K871413 for CIVCO STEPPER, Substantially Equivalent on 1987-07-14. Applicant: CIVCO Medical Instruments Co., Inc.. Device class: 1.

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-04-08
Decision date: 1987-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZX

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K914715 — PARALLELING GUIDES1994-02-16
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
K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER1985-07-11

More clearances from CIVCO Medical Instruments Co., Inc.

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K211270 — CIV-Clear cover2021-09-13
K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor2017-06-09
K160806 — Verza Guidance System2016-08-05

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.