The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Proximate Curved And Straight Intraluminal Staplers.
| Device ID | K983536 |
| 510k Number | K983536 |
| Device Name: | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS |
| Classification | Staple, Implantable |
| 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 | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1998-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036014069 | K983536 | 000 |
| 10705036003458 | K983536 | 000 |
| 10705036003465 | K983536 | 000 |
| 10705036003472 | K983536 | 000 |
| 10705036003519 | K983536 | 000 |
| 10705036003526 | K983536 | 000 |
| 10705036003533 | K983536 | 000 |
| 10705036003540 | K983536 | 000 |
| 20705036003448 | K983536 | 000 |
| 20705036003455 | K983536 | 000 |
| 20705036003462 | K983536 | 000 |
| 20705036003479 | K983536 | 000 |
| 20705036003516 | K983536 | 000 |
| 20705036003523 | K983536 | 000 |
| 20705036003530 | K983536 | 000 |
| 20705036003547 | K983536 | 000 |
| 30705036014052 | K983536 | 000 |
| 10705036003441 | K983536 | 000 |