The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Endoneedle.
| Device ID | K844619 |
| 510k Number | K844619 |
| Device Name: | ENDONEEDLE |
| Classification | Pneumoperitoneum Needle |
| Applicant | ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Contact | Jessica Warring |
| Correspondent | Jessica Warring ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-01-09 |