THE UNI-CLIP STAPLE— 510(k) K011716
Substantially EquivalentNew Deal, S.A.
FDA 510(k) clearance K011716 for THE UNI-CLIP STAPLE, Substantially Equivalent on 2001-08-30. Applicant: New Deal, S.A.. Device class: 2.
Clearance details
- Applicant
- New Deal, S.A.
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Potomac, MD, US
Recent devices under product code JDR
view allMore clearances from New Deal, S.A.
view allAdverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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 →
Recalls naming K011716
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011716.
Data sourced from openFDA. This site is unofficial and independent of the FDA.