GABBAY-FRATER SUTURE GUIDE— 510(k) K802093

Name: FDA 510(k) clearance K802093
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K802093 for GABBAY-FRATER SUTURE GUIDE, Substantially Equivalent on 1980-09-26. Applicant: Howmedica Corp.. Device class: 1.

Clearance details

Applicant: Howmedica Corp.
Product code: Code FZX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-09-02
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K914715 — PARALLELING GUIDES1994-02-16
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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

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K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
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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.