Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
Xaga Surgical · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Helsingborg
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Alnarpsgatan 81
- Statement or summary
- Summary
- Product code
- KNW
- Zip code
- SE-256 67
- Applicant
- Xaga Surgical
- Decision date
- 2025-02-27
- Decision code
- SESE
- Country code
- SE
- Device name
- Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
- Advisory committee
- GU
- Contact
- Anders Grim
- K number
- K242128
- Date received
- 2024-07-19
- Review advisory committee
- GU
- Postal code
- SE-256 67
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Instrument, Biopsy
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1075
- Device class
- 2
- Registration number
- 3014032451, 3030446844, 3018094310, 3042940295, 3008044552, 3004122598, 3006788678, 3007648417, 1226544, 9617616, 3021023752, 1835568, 3007748770, 1000484830, 3002806603, 3019807891, 2531475, 3030626857, 3022977243, 9617592, 3007162296, 3004962788, 3007137598, 1061124, 3006981798, 3011504993, 3044399745, 3007664053, 1221485, 2134812, 1722746, 3009050824, 3015980719, 3004111573, 3011245468, 3015806723, 3011137372, 3033589330, 2953359, 3044026004 +166 more
- FEI number
- 3014032451, 3030446844, 3018094310, 3042940295, 3008044552, 3004122598, 3006788678, 3007648417, 3021023752, 3007748770, 1000484830, 3002806603, 3019807891, 3030626857, 3002807847, 3022977243, 3007162296, 3004962788, 3007137598, 3006981798, 3011504993, 3044399745, 3007664053, 1221485, 1000434163, 3003015552, 3009050824, 1000123143, 3015980719, 3004111573, 3011245468, 3015806723, 3033589330, 3000206435, 3044026004, 3001236905, 2246552, 3006786907, 3000209794, 3015924373 +166 more