COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE— 510(k) K003958

Clearance details

Applicant

Coalescent Surgical

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2000-12-21

Decision date

2001-02-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, 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

• K040821 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES2004-04-23
• K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES2003-07-03
• K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES2003-01-17
• K023125 — COALESCENT U-CLIP- AND ACCESSORIES2002-12-18
• K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES2002-07-03

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 →