The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Endopath Dextrus Seal Cap Assembly With Accessories And Endopath Dextrus Fixed-length Access Retractors, Hap02.
| Device ID | K070198 |
| 510k Number | K070198 |
| Device Name: | ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Wendy Turner |
| Correspondent | Wendy Turner 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 | 2007-01-22 |
| Decision Date | 2007-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036002059 | K070198 | 000 |
| 30705036001984 | K070198 | 000 |
| 30705036001977 | K070198 | 000 |
| 30705036001960 | K070198 | 000 |