Accutrac
510(k) K110686
Accutrac is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Boston Scientific, cleared under FDA 510(k) K110686 on 28 Mar 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110686 | Date28 Mar 2011 | StatusActive |
Official records
- FDA 510(k) database K110686
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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