FDA applicant
Schoelly Fiberoptic GmbH
FDA records 12 decisions for Schoelly Fiberoptic GmbH (Denzlingen, DE) from 1999 to 2024: 12 510(k) clearances. Most are in product codes EOB (Nasopharyngoscope (Flexible Or Rigid)) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Schoelly Fiberoptic GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Schoelly Fiberoptic GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Schoelly”
FDA records each applicant name separately; these may or may not be the same firm.