510(k) K983365 ยท GWG Endoscope, Neurological
AESCULAP MINOP SYSTEM
| Applicant | Aesculap, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 18, 1998 |
| Received | Sep 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2026 | Aesculap Inc 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/ Open, Classified |
GWG | None listed |
| Sep 6, 2023 | Aesculap Implant Systems LLC For intraventricular indications mainly used for operations within the brain ventricles.
Product Code: FF399R Open, Classified |
GWG | None listed |
| Mar 20, 2017 | Aesculap Implant Systems LLC 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 treat Terminated |
GWG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.