The following data is part of a premarket notification filed by Ethicon Endo-surgery with the FDA for Megadyne Telescoping Smoke Evacuation Pencil - 10ft Tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft Tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector.
| Device ID | K200253 |
| 510k Number | K200253 |
| Device Name: | Megadyne Telescoping Smoke Evacuation Pencil - 10ft Tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft Tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery 475 Cale C Guaynabo, PR 00696 |
| Contact | Emily Nesbitt |
| Correspondent | Emily Nesbitt Ethicon Endo-Surgery, Inc. 4545 Creek Rd Cincinnati, OH 45242 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559105966 | K200253 | 000 |
| 10614559105580 | K200253 | 000 |
| 10614559105931 | K200253 | 000 |
| 10614559105948 | K200253 | 000 |
| 10614559105955 | K200253 | 000 |
| 10614559105962 | K200253 | 000 |
| 70614559105070 | K200253 | 000 |
| 30614559105034 | K200253 | 000 |
| 30614559105577 | K200253 | 000 |
| 30614559105584 | K200253 | 000 |
| 30614559105935 | K200253 | 000 |
| 30614559105942 | K200253 | 000 |
| 30614559105959 | K200253 | 000 |
| 10614559105573 | K200253 | 000 |