Endovations
Camp Hill, PA, US
Endovations appears in FDA device records in Camp Hill, PA. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 38
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 38 510(k) clearances for Endovations between 1986 and 1996. The busiest year on record is 1987, with 20. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 7 |
| 1987 | 20 |
| 1988 | 3 |
| 1989 | 1 |
| 1991 | 3 |
| 1994 | 3 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955413 | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER | FGE | Substantially Equivalent | |
| K942110 | INJECT-SNARE | FDI | Substantially Equivalent | |
| K944049 | OXYGEN MOUTHGUARD | MNK | Substantially Equivalent | |
| K934315 | ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME | KNS | Substantially Equivalent | |
| K913841 | 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH | FGE | Substantially Equivalent | |
| K913870 | 5MM MICROSCISSORS | GCJ | Substantially Equivalent | |
| K911155 | OVAL CUP BIOPSY FORCEP | FCF | Substantially Equivalent | |
| K892218 | ENDO-SPONGE | MNL | Substantially Equivalent | |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | FBK | Substantially Equivalent | |
| K873360 | ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG | KNT | Substantially Equivalent | |
| K875264 | WASHING CATHETER | OCX | Substantially Equivalent | |
| K874062 | ENTERON LIVER BIOPSY TRAY | KNW | Substantially Equivalent | |
| K874239 | CLEANING BRUSH | MNL | Substantially Equivalent | |
| K874016 | OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO | OCZ | Substantially Equivalent | |
| K874015 | HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12) | OCZ | Substantially Equivalent | |
| K874014 | OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) | OCZ | Substantially Equivalent | |
| K874013 | OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE | OCZ | Substantially Equivalent | |
| K874012 | OVAL CUP BIOPSY FORCEP (MODEL 18/5) | OCZ | Substantially Equivalent | |
| K874011 | OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) | OCZ | Substantially Equivalent | |
| K874010 | ROUND CUP HOT BIOPSY FORCEP (MODEL D-52) | OCZ | Substantially Equivalent | |
| K874009 | OVAL CUP HOT BIOPSY FORCEP (MODEL C-52) | OCZ | Substantially Equivalent | |
| K874008 | OVAL CUP HOT BIOPSY FORCEP (MODEL B-51) | OCZ | Substantially Equivalent | |
| K874007 | OVAL CUP HOT BIOPSY FORCEP (MODEL A-51) | OCZ | Substantially Equivalent | |
| K874006 | GRASPING TRIPOD FORCEP (MODEL 23/25) | OCZ | Substantially Equivalent | |
| K874005 | RAT TOOTH GRASPING FORCEP (MODEL 23/20) | OCZ | Substantially Equivalent | |
| K874004 | ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125) | OCZ | Substantially Equivalent | |
| K874003 | HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12) | OCZ | Substantially Equivalent | |
| K874164 | GUIDE WIRE | EZB | Substantially Equivalent | |
| K874063 | ENTERON ABDOMINAL PARACENTESIS TRAY | KDD | Unknown | |
| K872060 | WASHING/INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K871315 | ORAL ASPIRATOR | DYN | Substantially Equivalent | |
| K862059 | SHEATH, ENDOSCOPE | FGE | Substantially Equivalent | |
| K862424 | STEERABLE CATHETER SYSTEM | GCP | Substantially Equivalent | |
| K862058 | RAPID ENDOSCOPIC LAVAGE SYSTEM | OCX | Substantially Equivalent | |
| K862060 | POLYPECTOMY SNARE | KNS | Substantially Equivalent | |
| K860990 | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY | FGE | Substantially Equivalent | |
| K860997 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | Substantially Equivalent | |
| K860991 | SCLEROTHERAPY INJECTION CATHETER | KNT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- GCPEndoscope, Ac-Powered And Accessories
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- KNWInstrument, Biopsy
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal
- KDDKit, Surgical Instrument, Disposable
- GCJLaparoscope, General & Plastic Surgery
- DYNMouthpiece, Saliva Ejector
- FDISnare, Flexible
- FGEStents, Drains And Dilators For The Biliary Ducts
- EZBStylet For Catheter, Gastro-Urology
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain