Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,— 510(k) K160705
Substantially EquivalentY. Jacobs Medical, Inc.
FDA 510(k) clearance K160705 for Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,, Substantially Equivalent on 2016-11-23. Applicant: Y. Jacobs Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Y. Jacobs Medical, Inc.
- Product code
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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More clearances from Y. Jacobs Medical, Inc.
view allAdverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
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.