Pristine Scope
by Pristine Surgical 2 variants
510(k) K193161
Pristine Scope is a Class II device made by Pristine Surgical, cleared under FDA 510(k) K193161 on 21 Apr 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 | NumberK193161 | Date21 Apr 2020 | StatusActive |
Official records
- FDA 510(k) database K193161
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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