The following data is part of a premarket notification filed by Endo-therapeutics, Inc. with the FDA for Varices Injection Needle.
| Device ID | K012977 |
| 510k Number | K012977 |
| Device Name: | VARICES INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. Safety Harbor, FL 34695 -2908 |
| Contact | Todd Adkisson |
| Correspondent | Todd Adkisson ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. Safety Harbor, FL 34695 -2908 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-05 |
| Decision Date | 2001-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816207021062 | K012977 | 000 |
| 10816207021147 | K012977 | 000 |
| 10816207021154 | K012977 | 000 |
| 10816207021161 | K012977 | 000 |
| 10816207021215 | K012977 | 000 |
| 10816207020171 | K012977 | 000 |
| 10816207020942 | K012977 | 000 |
| 10816207021017 | K012977 | 000 |
| 10816207021031 | K012977 | 000 |
| 10816207021055 | K012977 | 000 |
| 10816207021130 | K012977 | 000 |