Iplan! Digital Templating
by Brainlab AG
510(k) K042543
Iplan! Digital Templating is a medical device (FDA Class II; FDA product code HAW, Neurological Stereotaxic Instrument) made by Brainlab AG, cleared under FDA 510(k) K042543 on 17 May 2005, 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 | NumberK042543 | Date17 May 2005 | StatusActive |
Official records
- FDA 510(k) database K042543
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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