Ambu® aScope Gastro; Ambu® aScope Gastro Large
Ambu A/S · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Ballerup
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Baltorpbakken 13
- Statement or summary
- Summary
- Product code
- FDS
- Zip code
- 2750
- Applicant
- Ambu A/S
- Decision date
- 2026-09-16
- Decision code
- SESE
- Country code
- DK
- Device name
- Ambu® aScope Gastro; Ambu® aScope Gastro Large
- Advisory committee
- GU
- Contact
- Martina Krautwald
- K number
- K261400
- Date received
- 2026-04-29
- Review advisory committee
- GU
- Postal code
- 2750
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Gastroscope And Accessories, Flexible/Rigid
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 1450997, 9617070, 3010202439, 3024021261, 3008627763, 3001675293, 3015525240, 3013247477, 3003782610, 3013944123, 3014769442, 3004644065, 9611680, 3009698186, 3010703925, 3015223550, 3014342096, 3015746529, 3010220595, 3004040397, 3011050570, 3021246306, 3042225166, 3044545674, 3004111573, 3018258446, 1528319, 3021691063, 9610617, 3015194986, 3008386005, 1649518, 3006161756, 3008797804, 3015612252, 3015136743, 9611112, 2183744, 3003790304, 3010141954 +32 more
- FEI number
- 1450997, 3024021261, 3008627763, 3001675293, 3015525240, 3013247477, 3003782610, 3013944123, 3014769442, 3002807795, 3004644065, 3009698186, 3010703925, 3015223550, 3014342096, 3003995201, 3010220595, 3002808127, 3011050570, 3021246306, 3008185830, 3042225166, 3004111573, 3018258446, 3004040397, 3021691063, 3044545674, 3015194986, 3002807134, 3008386005, 3015612252, 3015136743, 3008797804, 3008782585, 3002807969, 2183744, 3003790304, 3010141954, 3010288205, 3014605202 +32 more