MODIFICATION TO IMPLANTABLE CLIP— 510(k) K011236

Clearance details

Applicant

Applied Medical Resources Corp.

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2001-04-23

Decision date

2001-05-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Rancho Santa, CA, 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

• K252740 — Voyant® Open Fusion Device (EB240/Open Fusion)2025-11-04
• K252442 — Kii Structural Balloon Access System2025-10-31
• K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device2025-10-02
• K201212 — Voyant Open Fusion Device2020-06-05
• K200598 — Voyant Maryland Fusion Device2020-04-08

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-1621-2016 — Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.Class II·Terminated·Applied Medical Resources Corp·20160401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011236.