The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Disposable Flexible Surgical Cannula.
| Device ID | K931111 |
| 510k Number | K931111 |
| Device Name: | ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Sandra V Diggs |
| Correspondent | Sandra V Diggs 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 | 1993-03-04 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036011921 | K931111 | 000 |
| 30705036011914 | K931111 | 000 |
| 30705036011907 | K931111 | 000 |
| 30705036001991 | K931111 | 000 |