Weck Closure Systems: FDA clearances and approvals
Weck Closure Systems has 6 FDA 510(k) clearances (first 1998, latest 2001), across 2 product codes in 2 review panels. Median 510(k) review time: 86 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FZP | Clip, Implantable | 5 | 5 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent Weck Closure Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011660 | WECK CARDIAC PACING WIRES | LDF | 2001-08-21 | 84 |
| K003337 | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 | FZP | 2000-12-21 | 57 |
| K993157 | HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 | FZP | 1999-12-17 | 87 |
| K982944 | HEM-O-LOCK, MODEL 523935 | FZP | 1998-11-19 | 90 |
| K982941 | HEM-O-LOK MODEL NUMBERS 523900, 523970 | FZP | 1998-11-19 | 90 |
| K982313 | HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS | FZP | 1998-08-10 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Weck Closure Systems.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Weck Closure Systems have?
Weck Closure Systems has 6 FDA 510(k) clearances (first 1998, latest 2001), across 2 product codes in 2 review panels.
How long does FDA take to clear Weck Closure Systems's 510(k)s?
The median time from FDA receipt to decision across Weck Closure Systems's cleared 510(k)s is 86 days.
What devices does Weck Closure Systems make?
Its most frequent FDA product codes are FZP (Clip, Implantable, 5); LDF (Electrode, Pacemaker, Temporary, 1).
Has Weck Closure Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Weck Closure Systems. Related entities may recall under other names.
Next steps
- See all 6 Weck Closure Systems clearances with predicates and recalls
- Run predicate analysis for product code FZP, Weck Closure Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.