The following data is part of a premarket notification filed by Beacon Endoscopic with the FDA for Bnx Delivery System Pre-loaded With 19, 22 And 25 Gauge Needle, 19, 22 Or 25 Gauge Needles (individually Sterile-packed,.
| Device ID | K133008 |
| 510k Number | K133008 |
| Device Name: | BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, |
| Classification | Biopsy Needle |
| Applicant | BEACON ENDOSCOPIC 2000 COMMONWEALTH AVE STE 110 Auburndale, MA 02466 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant BEACON ENDOSCOPIC 2000 COMMONWEALTH AVE STE 110 Auburndale, MA 02466 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2013-11-20 |
| Summary: | summary |