BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
FDA 510(k) clearance K133008 · decided 2013-11-20
Clearance details
- K-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,
- Applicant
- Beacon Endoscopic
- Decision
- Substantially Equivalent
- Date received
- 2013-09-25
- Decision date
- 2013-11-20
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Auburndale, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.