Predicate Research Report · generated 2026-08-24 · Print / save as PDF · Save to account
Mgb Endoskopische Gerate GmbH (Berlin) · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092584 | LAPORT | Mgb Endoskopische Gerate GmbH (Berlin) | 2010-03-22 | 210 | 0 |
| K093194 | MGB DISPOSABLE RETRIEVAL BAG LAPBAG | Mgb Endoskopische Gerate GmbH (Berlin) | 2010-03-03 | 145 | 0 |
| K032544 | VP-1000; MED CAM 100; VP-3000A; MED CAM 300 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | 15 | 0 |
| K032545 | ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; | Mgb Endoskopische Gerate GmbH (Berlin) | 2003-09-02 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda