Government RegulationRegulation of Medical Devices in the European Union for more information. The CE mark for Revita was applied under the MDD, which has now been superseded by the MDR and we are currently working on obtaining MDR certification. Under the recently extended MDR transitional provisions, both (i) devices lawfully placed on the market pursuant to the MDD prior to May 26, 2021 and (ii) legacy devices lawfully placed on the market after May 26, 2021, in accordance with the transition...
Q2 FY2026 — expected 2026-09-14
| Filed | Period | Accession | Source | Full Text |
|---|---|---|---|---|
| 2026-03-24 | 2025-12-31 | 0001193125-26-121793 | EDGAR | 127K words |
| 2025-03-03 | 2024-12-31 | 0000950170-25-030807 | EDGAR | — |
| 2024-04-01 | 2023-12-31 | 0000950170-24-038866 | EDGAR | — |
| Filed | Period | Accession | Source | Full Text |
|---|---|---|---|---|
| 2025-11-12 | 2025-09-30 | 0001193125-25-277531 | EDGAR | 76K words |
| 2025-08-12 | 2025-06-30 | 0000950170-25-107297 | EDGAR | — |
| 2025-05-13 | 2025-03-31 | 0000950170-25-070275 | EDGAR | — |
| 2024-11-12 | 2024-09-30 | 0000950170-24-125293 | EDGAR | — |
| 2024-08-14 | 2024-06-30 | 0000950170-24-096968 | EDGAR | — |
| 2024-05-13 | 2024-03-31 | 0000950170-24-058634 | EDGAR | — |
| Filed | Accession | Source | Full Text |
|---|---|---|---|
| 2026-03-24 | 0001193125-26-121780 | EDGAR | 4K words |
| 2026-03-17 | 0001193125-26-110923 | EDGAR | — |
| 2026-02-26 | 0001193125-26-073374 | EDGAR | — |
| 2026-01-29 | 0001193125-26-028228 | EDGAR | — |
| 2026-01-06 | 0001193125-26-003452 | EDGAR | — |
| 2026-01-05 | 0001193125-26-001492 | EDGAR | — |
| 2025-12-16 | 0001193125-25-319524 | EDGAR | — |
| 2025-12-02 | 0001193125-25-304486 | EDGAR | — |
| 2025-11-12 | 0001193125-25-277524 | EDGAR | — |
| 2025-10-03 | 0001193125-25-230096 | EDGAR | — |
53 total filings indexed. 34 additional filings (S-1, DEF 14A, etc.) View all (JSON) · SEC EDGAR
| CIK | 0001572616 |
| Ticker | GUTS |
| Exchange | Nasdaq |
| SIC | 3841: Surgical & Medical Instruments & Apparatus |
| Incorporated | DE |
| Website | https://www.fractyl.com |
| Listed | 2024-02-02 |
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