The following data is part of a premarket notification filed by Aponos Medical Corp. with the FDA for Padlock Clip-12.
| Device ID | K120814 |
| 510k Number | K120814 |
| Device Name: | PADLOCK CLIP-12 |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | APONOS MEDICAL CORP. 16 HILLSIDE RD. Kingston, NH 03848 |
| Contact | John Fee |
| Correspondent | John Fee APONOS MEDICAL CORP. 16 HILLSIDE RD. Kingston, NH 03848 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816765013809 | K120814 | 000 |
| 00816765013793 | K120814 | 000 |
| 00724995184247 | K120814 | 000 |