3NT endoscopy system
510(k) K162916
3NT endoscopy system is a Class II device made by 3nt Medical, Ltd., cleared under FDA 510(k) K162916 on 24 Feb 2017, 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 | NumberK162916 | Date24 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K162916
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOB
- FDA applicant
- 3nt Medical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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