The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable.
| Device ID | K182801 |
| 510k Number | K182801 |
| Device Name: | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Contact | Jennifer Siu |
| Correspondent | Jennifer Siu Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-02 |
| Decision Date | 2018-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704081760 | K182801 | 000 |
| 10886704081722 | K182801 | 000 |
| 10886704081692 | K182801 | 000 |
| 10381780532873 | K182801 | 000 |