Endo-Therapeutics, Inc.
Clearwater, FL, US
ENDO-THERAPEUTICS, INC. appears in FDA device records in Clearwater, FL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Endo-Therapeutics, Inc. between 1993 and 2009. The busiest year on record is 1993, with 2. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 2001 | 2 |
| 2003 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | KNS | Substantially Equivalent | |
| K023603 | ENDO-GLIDE GUIDEWIRE | OCY | Substantially Equivalent | |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES | GEI | Substantially Equivalent | |
| K012977 | VARICES INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | |
| K925392 | BIOPSY FORCEPS | FCL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1056129 | 1000132436 | ENDO-THERAPEUTICS, INC. | 15251 Roosevelt Blvd Ste 204, CLEARWATER, FL 33760 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KDQBottle, Collection, Vacuum
- GEEBrush, Biopsy, General & Plastic Surgery
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- PKLHemostatic Metal Clip For The Gi Tract
- KNWInstrument, Biopsy
- FGXSnare, Non-Electrical
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0270-2023 | eSuction Small Cavity, Model ET2005 | Improper device regulatory classification | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain