The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endoscopic Instruments.
| Device ID | K984240 |
| 510k Number | K984240 |
| Device Name: | ENDOPATH ENDOSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Jackie A Strasser |
| Correspondent | Jackie A Strasser ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-06-22 |
| Summary: | summary |