BTL-398
BTL Industries, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Marlborough
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 362 Elm St.
- Statement or summary
- Summary
- Product code
- KPI
- Zip code
- 01752
- Applicant
- BTL Industries, Inc.
- Decision date
- 2025-02-10
- Decision code
- SESE
- Country code
- US
- Device name
- BTL-398
- Advisory committee
- GU
- Contact
- David Chmel
- K number
- K241516
- State
- MA
- Date received
- 2024-05-29
- Review advisory committee
- GU
- Postal code
- 01752
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5320
- Device class
- 2
- Registration number
- 3014405438, 3006636961, 3025376109, 3017936974, 3017264244, 9613462, 9616877, 3007543044, 9680487, 3005170249, 3048050691, 8010720, 9617486, 3010511300, 1528161, 1224842, 3017448360, 3004839404, 1063324, 3003446042, 3006850006, 3012316249, 3045753434, 3035374386, 3027329006, 3042709404, 1718873, 3006897018, 3009617411, 3019822804, 3021815, 3011905669, 3009736547, 3010405397, 3012477715, 3004049909, 3013426279, 3009466220, 3027135885, 3012697062
- FEI number
- 1000639819, 3014405438, 1000442645, 3006636961, 3025376109, 7759, 1000597018, 3017936974, 3027135885, 3017264244, 3003382542, 3007543044, 3005170249, 3048050691, 3010511300, 3017448360, 3002552319, 3004839404, 3003446042, 3006850006, 3012316249, 3045753434, 3035374386, 3027329006, 3042709404, 1718873, 3006897018, 3009617411, 3019822804, 1000122747, 3021815, 3011905669, 3009736547, 3010405397, 3012477715, 3004049909, 3013426279, 3009466220, 1000513601, 3012697062