The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Ethicon Endo-surgery Linear Cutter 55mm (ntlc55),selectable Cartridge 55 / 75mm (sr55/75) ,linear Cutter 75mm (ntlc75).
| Device ID | K092577 |
| 510k Number | K092577 |
| Device Name: | ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Abhilasha Mukherjee |
| Correspondent | Abhilasha Mukherjee 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 | 2009-08-21 |
| Decision Date | 2009-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036002837 | K092577 | 000 |
| 30705036002820 | K092577 | 000 |
| 30705036002622 | K092577 | 000 |
| 30705036002615 | K092577 | 000 |