KARL STORZ NAV1 Electromagnetic Navigation System
by Karl Storz Endoscopy-America, Inc. 510(k)
Active
510(k) K161555
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161555 | Date21 Oct 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 8 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PGW
- FDA applicant
- Karl Storz Endoscopy America, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent