FDA applicant

Weck Closure Systems

Research Triangle Park, NC6 decisions1998–20015 recalls

FDA records 6 decisions for Weck Closure Systems (Research Triangle Park, NC) from 1998 to 2001: 6 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and LDF (Electrode, Pacemaker, Temporary). Its devices cite 3 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Weck Closure Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Weck Closure Systems since 2007.

Recalls per year

1in 2013

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Weck Closure Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Weck Closure Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Weck”

FDA records each applicant name separately; these may or may not be the same firm.

Weck Endoscopy 4 Weck 2 Weck Surgical Systems 1

Weck Closure Systems

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Weck”