The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Ultra Veress Needle.
| Device ID | K983925 |
| 510k Number | K983925 |
| Device Name: | ENDOPATH ULTRA VERESS NEEDLE |
| Classification | Insufflator, Laparoscopic |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Edwin O Billips |
| Correspondent | Edwin O Billips ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036013420 | K983925 | 000 |