The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ultracision Harmonic Scalpel Blades, Model Dh105,dh145,sh105, Sh145,hc145.
| Device ID | K010898 |
| 510k Number | K010898 |
| Device Name: | ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ruth Ann Wood |
| Correspondent | Ruth Ann Wood ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-05-31 |