ADAPT for Gamma3
510(k) K202749
ADAPT for Gamma3 is a Class II device made by Stryker GmbH, cleared under FDA 510(k) K202749 on 18 Dec 2020, 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 | NumberK202749 | Date18 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K202749
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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