PARALLELING GUIDES— 510(k) K914715

Name: FDA 510(k) clearance K914715
Creator: U.S. Food and Drug Administration
Published: 1994-02-16

Substantially Equivalent

Implant Corp. of America

FDA 510(k) clearance K914715 for PARALLELING GUIDES, Substantially Equivalent on 1994-02-16. Applicant: Implant Corp. of America. Device class: 1.

Clearance details

Applicant: Implant Corp. of America
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-10-18
Decision date: 1994-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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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
K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER1985-07-11

More clearances from Implant Corp. of America

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K914714 — BONE DRILLS OR TAPS1993-11-15
K914724 — ADA SHANK EXTENSION1993-07-27

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.