A.C.L. GUIDE KIT— 510(k) K862564

Name: FDA 510(k) clearance K862564
Creator: U.S. Food and Drug Administration
Published: 1986-08-18

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K862564 for A.C.L. GUIDE KIT, Substantially Equivalent on 1986-08-18. Applicant: Aspen Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-07-03
Decision date: 1986-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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
K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY1985-12-24
K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER1985-07-11

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K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT1998-04-21
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K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT1996-07-11
K960296 — 4000 ETM1996-02-20
K953081 — BEAMER PLUS1995-10-30

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.