The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ultracision Harmonic Scalpel Blades With Protective Sleeve, Models Dh105, Dh145, Sh105, Sh145.
| Device ID | K012176 |
| 510k Number | K012176 |
| Device Name: | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ruth A Wood |
| Correspondent | Ruth A 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 | 2001-07-12 |
| Decision Date | 2001-10-01 |
| Summary: | summary |