GENICON CLIP APPLIER— 510(k) K030269

Clearance details

Applicant

Genicon, LC

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2003-01-27

Decision date

2003-03-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Orlando, FL, US

• K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips2026-07-20
• K253781 — InnoClip Clip Applier2025-12-22
• K253903 — InnoClip Disposable Clip Applier2025-12-22
• K250643 — Disposable Polymer Ligation Clips2025-11-20
• K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03

• K030174 — GENICON LAPAROSCOPES2003-06-19
• K002542 — REUSABLE CANNULA2000-10-23
• K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-2002000-06-20
• K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-1011999-07-15
• K982472 — GENICON TROCAR1999-02-04

Death

11

Injury

726

Malfunction

10,830

Other

1

Total

11,568

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 →

• Z-0310-2021 — A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intendedClass II·Ongoing·Genicon, Inc.·20200917

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030269.