The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endoscopic Tissue Fastening System (etfs).
| Device ID | K972679 |
| 510k Number | K972679 |
| Device Name: | ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Lorri Chavez |
| Correspondent | Lorri Chavez 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 | 1997-07-16 |
| Decision Date | 1997-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036002929 | K972679 | 000 |
| 30705036002912 | K972679 | 000 |
| 30705036002905 | K972679 | 000 |
| 30705036002899 | K972679 | 000 |
| 30705036002882 | K972679 | 000 |