HEM-O-LOK MODEL NUMBERS 523900, 523970— 510(k) K982941
Substantially EquivalentWeck Closure Systems
FDA 510(k) clearance K982941 for HEM-O-LOK MODEL NUMBERS 523900, 523970, Substantially Equivalent on 1998-11-19. Applicant: Weck Closure Systems. Device class: 2.
Clearance details
- Applicant
- Weck Closure Systems
- Product code
- Code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Research Triangle Park, NC, US
Recent devices under product code FZP
view allMore clearances from Weck Closure Systems
view all- K011660 — WECK CARDIAC PACING WIRES
- K003337 — HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
- K993157 — HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
- K982944 — HEM-O-LOCK, MODEL 523935
- K982313 — HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.