The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Enseal Tissue Sealing Devices Model: Nseal514h-535h, Nseal514rh-535rh.
| Device ID | K101520 |
| 510k Number | K101520 |
| Device Name: | ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD ML#132 Cincinatti, OH 45242 |
| Contact | Ruth Wood |
| Correspondent | Ruth Wood ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD ML#132 Cincinatti, 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 | 2010-06-02 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036013805 | K101520 | 000 |