The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Ethicon Circular Stapler, Ethicon Circular Stapler -xl Sealed.
| Device ID | K181653 |
| 510k Number | K181653 |
| Device Name: | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed |
| Classification | Staple, Implantable |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Sigfrido Delgado |
| Correspondent | Rubina Dosani Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-22 |
| Decision Date | 2018-09-18 |
| Summary: | summary |