FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StitchKit
K Number: K142639
·
Decision Dec 16, 2014
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- StitchKit
- K Number
- K142639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origami Surgical, LLC
- Date Received
- September 17, 2014
- Decision Date
- December 16, 2014
- Product Code
- GAW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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