The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ultracision Harmonic Scalpel Coagulating Shears, Models Lcs-c5, Lcs-c1, Cs-23c, Cs-231, Cs-14c, Cs-141.
| Device ID | K993054 |
| 510k Number | K993054 |
| Device Name: | ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 |
| 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 | 1999-09-13 |
| Decision Date | 1999-12-09 |
| Summary: | summary |