The following data is part of a premarket notification filed by Sharpe Endosurgical Corp. with the FDA for Sharp Endoknot Pusher.
| Device ID | K914967 |
| 510k Number | K914967 |
| Device Name: | SHARP ENDOKNOT PUSHER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SHARPE ENDOSURGICAL CORP. C/O PALADIN MEDICAL,INC. P.O.BOX 560 Still Water, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan SHARPE ENDOSURGICAL CORP. C/O PALADIN MEDICAL,INC. P.O.BOX 560 Still Water, MN 55082 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-05 |
| Decision Date | 1991-11-22 |