GluStitch Twist Tissue Adhesive— 510(k) K150032
Substantially EquivalentGlustitch, Inc.
FDA 510(k) clearance K150032 for GluStitch Twist Tissue Adhesive, Substantially Equivalent on 2016-01-14. Applicant: Glustitch, Inc.. Device class: 2.
Clearance details
- Applicant
- Glustitch, Inc.
- Product code
- Code MPN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Delta, CA
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More clearances from Glustitch, Inc.
view allAdverse events under product code MPN
product code MPN- Injury
- 856
- Other
- 1
- Total
- 857
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.