Scholly Fiberoptic Gmbh FDA Record
- Latest inspection NAI · Jun 30, 2016
- No warning letters matched by name
Scholly Fiberoptic Gmbh has 1 FDA recall, 2 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Scholly Fiberoptic Gmbh" is on file.
- Latest recall
- Z-2364-2023 · Class II · Jun 23, 2023
- Latest inspection
- Jun 30, 2016 · NAI
- Latest 510(k)
- Dec 17, 2014
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 3 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2364-2023 | Class II | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for… | Jun 23, 2023 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 30, 2016 | Denzlingen, Germany | Devices | No Action Indicated (NAI) | 3002808088 |
| Jun 6, 2013 | Denzlingen, Germany | Devices | No Action Indicated (NAI) | 3002808088 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808088 | Denzlingen, Germany | 2 | Jun 30, 2016 |
Scholly Fiberoptic Gmbh and the FDA: common questions
Has Scholly Fiberoptic Gmbh received an FDA warning letter?
No FDA warning letter addressed to the name "Scholly Fiberoptic Gmbh" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Scholly Fiberoptic Gmbh received an FDA Form 483?
FDA has not published a Form 483 for "Scholly Fiberoptic Gmbh" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Scholly Fiberoptic Gmbh?
The most recent FDA inspection on file ended Jun 30, 2016 at Denzlingen, Germany and was classified NAI. FDA has 2 inspections of Scholly Fiberoptic Gmbh on file.
Has Scholly Fiberoptic Gmbh had an FDA recall?
Yes. Scholly Fiberoptic Gmbh has 1 FDA recall on record. The most recent started Jun 23, 2023.
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