The following data is part of a premarket notification filed by Endovations with the FDA for Oval Cup Biopsy Forcep.
| Device ID | K911155 |
| 510k Number | K911155 |
| Device Name: | OVAL CUP BIOPSY FORCEP |
| Classification | Instrument, Biopsy, Mechanical, Gastrointestinal |
| Applicant | ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
| Contact | Jane E Predix |
| Correspondent | Jane E Predix ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
| Product Code | FCF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-08-07 |