AESCULAP MINOP SYSTEM
FDA 510(k) clearance K983365 · decided 1998-12-18
Clearance details
- K-number
- K983365
- Device name
- AESCULAP MINOP SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-24
- Decision date
- 1998-12-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GWG
- Device class
- 2
- Regulation number
- 882.1480
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog N recall (Z-1485-2026) | Aesculap Inc | 2026-03-02 |
| For intraventricular indications mainly used for operations within the brain ventricles. P recall (Z-2518-2023) | Aesculap Implant Systems LLC | 2023-09-06 |
| AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar recall (Z-1814-2017) | Aesculap Implant Systems LLC | 2017-03-20 |