← FDA Medical Device Classifications
Stapler, Skin
QQS · Class I — Low Risk (general controls) · General Hospital · 21 CFR 878.4740
Classification
- FDA Product Code
QQS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 878.4740
- Review panel
- SU
- Medical specialty
- General Hospital
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 50
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown