American Endoscopy, Inc.
Medical device manufacturer in Mentor, OH.
19510(k) clearances
0PMA approvals
0recalls
Device types
- KOD Catheter, Urological 2
- KNS Unit, Electrosurgical, Endoscopic (With Or… 2
- FGE Stents, Drains And Dilators For The Biliary… 2
- GEE Brush, Biopsy, General & Plastic Surgery 1
- OCZ Endoscopic Grasping/Cutting Instrument… 1
- ODD Endoscopic Retrograde Cholangiopancreatograp… 1
- GAA Needle, Aspiration And Injection, Disposable 1
- OCX Endoscopic Irrigation/Suction System 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- NVE Washer, Cleaner, Automated, Endoscope 1
- KNT Tubes, Gastrointestinal (And Accessories) 1
- GCP Endoscope, Ac-Powered And Accessories 1
- FCL Forceps, Biopsy, Non-Electric 1
- KTI Bronchoscope Accessory 1
- FFT Electrode, Ph, Stomach 1
- KNQ Dilator, Esophageal 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K853274 | American Dilatation SystemKNQ · Traditional | 10/17/1985SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | 07/19/1984SE |
| K833491 | Endo Bite BlockKTI · Traditional | 04/25/1984SE |
| K840818 | Biopsy ForcepsFCL · Traditional | 04/13/1984SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | 01/03/1984SE |
| K833492 | Percutaneous Endoscopic GastroscopyKNT · Traditional | 11/29/1983SE |
| K832458 | Automatic EndoscopeNVE · Traditional | 10/20/1983SE |
| K821818 | Retrieval BalloonsKOD · Traditional | 09/24/1982SE |
| K821819 | Pigtail StentsFGE · Traditional | 08/20/1982SE |
| K822062 | Ball Tip Coagulating ElectrodesGEI · Traditional | 08/19/1982SE |
| K821817 | Pigtail Nasal CathetersFGE · Traditional | 08/10/1982SE |
| K822061 | Lavaging CathetersOCX · Traditional | 07/20/1982SE |
| K821697 | Injection Aspirating NeedlesGAA · Traditional | 06/25/1982SE |
| K820431 | E.R.C.P. CannulasODD · Traditional | 04/09/1982SE |
| K820430 | Diathermic SnaresKNS · Traditional | 04/08/1982SE |
| K820429 | Spiral Stone and Retrieval BasketsOCZ · Traditional | 04/08/1982SE |
| K820240 | PapillotomesKNS · Traditional | 03/26/1982SE |
| K820239 | Retrieval ForcepsKOD · Traditional | 03/26/1982SE |
| K820259 | Sterile Cytology BrushesGEE · Traditional | 03/05/1982SE |