The following data is part of a premarket notification filed by Surgrx, Inc. with the FDA for Enseal Powertip,nseal-514d,-525d,-535d,-545d,-514rd,-525rd,-535rd,-545rd, Etrio-314d,-325d,-335d,-345d, Enseal Universal.
| Device ID | K081129 |
| 510k Number | K081129 |
| Device Name: | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGRX, INC. 101 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Linda Oleson |
| Correspondent | Linda Oleson SURGRX, INC. 101 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2008-07-28 |
| Summary: | summary |