The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. D/b/a Estech with the FDA for Estech Cobra Adhere Xl 2 Surgical System.
| Device ID | K113475 |
| 510k Number | K113475 |
| Device Name: | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Contact | Tamer Ibrahim |
| Correspondent | Tamer Ibrahim ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2012-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354012835 | K113475 | 000 |
| 00818354012828 | K113475 | 000 |
| 00818354012811 | K113475 | 000 |