The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Stone Extractor, Grasping Forceps.
| Device ID | K935737 |
| 510k Number | K935737 |
| Device Name: | STONE EXTRACTOR, GRASPING FORCEPS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. Watertown, MA 02472 -2407 |
| Contact | Lorraine M Hanley |
| Correspondent | Lorraine M Hanley BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. Watertown, MA 02472 -2407 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1994-09-07 |