Pristine Scope
by Pristine Surgical 2 variants
510(k) K183165
Pristine Scope is a Class II device made by Pristine Surgical, cleared under FDA 510(k) K183165 on 16 Jan 2019, 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 | NumberK183165 | Date16 Jan 2019 | StatusActive |
Official records
- FDA 510(k) database K183165
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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