Cytrellis Biosystems, Inc. FDA Record
- No warning letters matched by name
Cytrellis Biosystems, Inc. has 2 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cytrellis Biosystems, Inc." is on file.
- Latest recall
- Z-2393-2023 · Class II · Jun 23, 2023
- Latest 510(k)
- Oct 30, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 2 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | 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-2393-2023 | Class II | ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the… | Jun 23, 2023 |
| Z-1648-2023 | Class II | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for… | Apr 7, 2023 |
Cytrellis Biosystems, Inc. and the FDA: common questions
Has Cytrellis Biosystems, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Cytrellis Biosystems, Inc." 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 Cytrellis Biosystems, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Cytrellis Biosystems, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
Has Cytrellis Biosystems, Inc. had an FDA recall?
Yes. Cytrellis Biosystems, Inc. has 2 FDA recalls on record. The most recent started Jun 23, 2023.
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