510(k) K172907 ยท HBB Motor, Drill, Pneumatic
ELAN 4 Air Motor System
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Sep 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172907
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. Open, Classified |
HBB | None listed |
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. Open, Classified |
HBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.