The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Endopath Disposable Pneumoperitoneum Needle.
| Device ID | K910875 |
| 510k Number | K910875 |
| Device Name: | ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE |
| Classification | Apparatus, Pneumoperitoneum, Automatic |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John Paulson |
| Correspondent | John Paulson ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | FDP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40705036012970 | K910875 | 000 |
| 40705036012963 | K910875 | 000 |