Graft Delivery Device with Integrated Stylet— 510(k) K151543

Name: FDA 510(k) clearance K151543
Creator: U.S. Food and Drug Administration
Published: 2015-07-07

Substantially Equivalent

Micromedics, Inc. (D/B/A Nordson Medical)

FDA 510(k) clearance K151543 for Graft Delivery Device with Integrated Stylet, Substantially Equivalent on 2015-07-07. Applicant: Micromedics, Inc. (D/B/A Nordson Medical). Device class: 2.

Clearance details

Applicant: Micromedics, Inc. (D/B/A Nordson Medical)
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2015-06-08
Decision date: 2015-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K173385 — Graft Delivery, DePuy Synthes2017-11-30
K172672 — Endoscopic Applicator, 41 cm2017-10-06
K162077 — Laparoscopic Spray Applicator with Spinning Luers2016-08-11

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.