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 | K201280 |
| 510k Number | K201280 |
| 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 | Nathan Anderson |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-13 |
| Decision Date | 2020-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036022937 | K201280 | 000 |
| 20705036022944 | K201280 | 000 |
| 20705036022920 | K201280 | 000 |
| 20705036022913 | K201280 | 000 |