The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Resposable Trocar System.
| Device ID | K971738 |
| 510k Number | K971738 |
| Device Name: | ENDOPATH RESPOSABLE TROCAR SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ivan S Placko |
| Correspondent | Ivan S Placko ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705036012245 | K971738 | 000 |
| 30705036000451 | K971738 | 000 |
| 30705036000468 | K971738 | 000 |
| 30705036000505 | K971738 | 000 |
| 30705036000512 | K971738 | 000 |
| 30705036000567 | K971738 | 000 |
| 30705036000598 | K971738 | 000 |
| 30705036000611 | K971738 | 000 |
| 30705036000659 | K971738 | 000 |
| 30705036000697 | K971738 | 000 |
| 30705036000710 | K971738 | 000 |
| 10705036011972 | K971738 | 000 |
| 10705036012047 | K971738 | 000 |
| 10705036012153 | K971738 | 000 |
| 40705036012192 | K971738 | 000 |
| 30705036000420 | K971738 | 000 |