The following data is part of a premarket notification filed by E.d.medical Ltd. with the FDA for The Needle Catcher.
| Device ID | K051281 |
| 510k Number | K051281 |
| Device Name: | THE NEEDLE CATCHER |
| Classification | Forceps |
| Applicant | E.D.MEDICAL LTD. 32 CRANMORE AVENUE LISBURN RD Belfast, GB Bt96jh |
| Contact | Brian Mcnicholl |
| Correspondent | Brian Mcnicholl E.D.MEDICAL LTD. 32 CRANMORE AVENUE LISBURN RD Belfast, GB Bt96jh |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2005-09-08 |
| Summary: | summary |