Navigator Flex Ureteral Access Sheath Set
Boston Scientific Corporation · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Marlborough
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 100 Boston Scientific Way
- Statement or summary
- Summary
- Product code
- FED
- Zip code
- 01752
- Applicant
- Boston Scientific Corporation
- Decision date
- 2026-08-04
- Decision code
- SESE
- Country code
- US
- Device name
- Navigator Flex Ureteral Access Sheath Set
- Advisory committee
- GU
- Contact
- Uma Ramnanan
- K number
- K261915
- State
- MA
- Date received
- 2026-06-09
- Review advisory committee
- GU
- Postal code
- 01752
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3005814162, 8043903, 3045323889, 3021023752, 3014683069, 3013247477, 3005580113, 3032959393, 2431166, 1000121056, 3012797688, 2029275, 3014644276, 1820334, 3010421104, 1647149, 3030733800, 2936485, 3015309643, 3004361445, 9610773, 3030446844, 3042172882, 3002808148, 3009420598, 3016881508, 9611668, 1037955, 3034608931, 8043746, 1018233, 3013944123, 3005941719, 3010273872, 3033589330, 3015225571, 3011050570, 1724474, 1000393132, 3044858680 +77 more
- FEI number
- 3005814162, 3045323889, 3021023752, 3014683069, 3013247477, 3005580113, 3032959393, 3003995201, 1000514656, 1000121056, 3012797688, 1820334, 3010421104, 1000136543, 3030733800, 1000120613, 2936485, 3015309643, 3004361445, 3006149253, 1000122656, 3002807135, 1000160215, 3030446844, 3042172882, 3002806565, 3002808148, 3009420598, 3016881508, 1037955, 3034608931, 1018233, 3013944123, 3002807795, 3002808088, 3010273872, 3033589330, 3015225571, 3002808127, 3011050570 +77 more