AESCULAP MINOP SYSTEM— 510(k) K983365
Substantially EquivalentAesculap, Inc.
FDA 510(k) clearance K983365 for AESCULAP MINOP SYSTEM, Substantially Equivalent on 1998-12-18. Applicant: Aesculap, Inc.. Device class: 2.
Clearance details
- Applicant
- Aesculap, Inc.
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code GWG
view allMore clearances from Aesculap, Inc.
view allAdverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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 K983365
K-number listed on FDA's recall record- Z-1485-2026 — Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
- Z-2518-2023 — For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Z-1814-2017 — AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983365.
Data sourced from openFDA. This site is unofficial and independent of the FDA.