ELAN 4 Air Motor System— 510(k) K172907
Substantially EquivalentAesculap, Inc.
FDA 510(k) clearance K172907 for ELAN 4 Air Motor System, Substantially Equivalent on 2018-11-09. Applicant: Aesculap, Inc.. Device class: 2.
Clearance details
- Applicant
- Aesculap, Inc.
- Product code
- Code HBB
- Device class
- Class 2
- Regulation
- 21 CFR 882.4370
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code HBB
view allMore clearances from Aesculap, Inc.
view allAdverse events under product code HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172907
K-number listed on FDA's recall record- Z-0026-2026 — AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- Z-0027-2026 — AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172907.
Data sourced from openFDA. This site is unofficial and independent of the FDA.