Endo-Therapeutics, Inc.
FDA Regulatory Profile
Endo-Therapeutics, Inc. appears in FDA public data with 1 recall, 7 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0270-2023, Class II) was initiated on October 24, 2022. Its most recent 510(k) clearance was granted on November 25, 2009.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0270-2023 | Class II | eSuction Small Cavity, Model ET2005 | October 24, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | November 25, 2009 |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | June 27, 2003 |
| K023603 | ENDO-GLIDE GUIDEWIRE | February 19, 2003 |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES | November 8, 2001 |
| K012977 | VARICES INJECTION NEEDLE | November 2, 2001 |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | December 6, 1993 |
| K925392 | BIOPSY FORCEPS | November 5, 1993 |