Submission Details
| 510(k) Number | K250893 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2025 |
| Decision Date | September 04, 2025 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Ball Joint Guide Array (66295)
Sep 2025
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K250893 is an FDA 510(k) clearance for the Ball Joint Guide Array (66295), a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on September 4, 2025, 163 days after receiving the submission on March 25, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.
Device Classification
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
Manufacturer
Similar Devices — HAW Neurological Stereotaxic Instrument
All 420
K231897 · Medivis, Inc.
· Oct 2025
K251317 · Intravent Medical Partners
· Sep 2025
K250505 · Phasor Health, LLC
· Jul 2025
K242575 · Brain Navi Biotechnology Co., Ltd.
· May 2025
K241327 · Claronav
· Feb 2025
K243698 · Brainlab AG
· Jan 2025
More from Bayer Medical Care, Inc.
View all
K252891
· DXT · Feb 2026
K200280
· PQH · Jul 2020
K192370
· DXT · Dec 2019
K193028
· DXT · Dec 2019
K182273
· DXT · Nov 2018