The following data is part of a premarket notification filed by Endovations with the FDA for Oval Cup With Needle Biopsy Forcep (model 23/1).
| Device ID | K874014 |
| 510k Number | K874014 |
| Device Name: | OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Susan P Bjorkman |
| Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-01 |
| Decision Date | 1987-12-29 |