The following data is part of a premarket notification filed by Inx Medical with the FDA for Nexus Hemorrhoid Ligator.
| Device ID | K131282 |
| 510k Number | K131282 |
| Device Name: | NEXUS HEMORRHOID LIGATOR |
| Classification | Ligator, Hemorrhoidal |
| Applicant | INX MEDICAL 1819 CLARKSON ROAD SUITE 206 Chesterfield, MO 63017 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden INX MEDICAL 1819 CLARKSON ROAD SUITE 206 Chesterfield, MO 63017 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861815000469 | K131282 | 000 |
| 00861815000476 | K131282 | 000 |
| 00861815000414 | K131282 | 000 |