The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Grasp Forceps/scissors/needle Holder/dissector.
| Device ID | K931340 |
| 510k Number | K931340 |
| Device Name: | GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR |
| Classification | Endoscope, Battery-powered And Accessories |
| Applicant | BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Contact | Daphne D Maurer |
| Correspondent | Daphne D Maurer BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Product Code | GCS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-16 |
| Decision Date | 1993-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403052194 | K931340 | 000 |
| 10885403052101 | K931340 | 000 |
| 10885403052088 | K931340 | 000 |
| 10885403052071 | K931340 | 000 |