The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Endopath Xcel Bladeless Trocar With Optiview Technology Endopath Xcel Blunt Tip Trocar With Optiview Technology Endopath.
| Device ID | K122511 |
| 510k Number | K122511 |
| Device Name: | ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Emily Kruetzkamp |
| Correspondent | Emily Kruetzkamp ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2012-10-01 |
| Summary: | summary |