colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Ovesco Endoscopy AG · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Tuebingen
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Friedrich-Miescher-Strasse 9
- Statement or summary
- Summary
- Product code
- PKL
- Zip code
- 72076
- Applicant
- Ovesco Endoscopy AG
- Decision date
- 2026-09-14
- Decision code
- SESE
- Country code
- DE
- Device name
- colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
- Advisory committee
- GU
- Contact
- Antonio Caputo
- K number
- K253481
- Date received
- 2025-10-14
- Review advisory committee
- GU
- Postal code
- 72076
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Hemostatic Metal Clip For The Gi Tract
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.4400
- Device class
- 2
- Registration number
- 3014328942, 3021023752, 3016696686, 3017178358, 3009217531, 3017210488, 3014769442, 9611680, 3010273872, 3009747810, 3010432890, 3025311469, 1000121056, 3011050570, 3013526170, 1047843, 3006696607, 3013557562, 1528319, 2183446, 3017390965, 3014620201, 9681260, 3007695959, 3008797804, 3030733800, 1056129, 1061927, 3036773433, 3006621103, 3010288205, 3015142721, 3031276312, 3033841914, 3035434483, 3012494290, 2246552, 1037905, 3013440400, 3012042439 +14 more
- FEI number
- 3014328942, 3021023752, 3016696686, 3017178358, 3009217531, 3017210488, 3014769442, 3002807795, 3010273872, 3010432890, 3009747810, 3025311469, 3003995201, 1000121056, 3011050570, 3013526170, 1047843, 3006696607, 3013557562, 2183446, 3000203000, 3017390965, 3002806816, 3014620201, 3007695959, 3008797804, 3030733800, 3002807969, 3036773433, 1000132436, 3010288205, 3015142721, 3031276312, 3006621103, 3033841914, 3035434483, 3012494290, 2246552, 1037905, 3013440400 +14 more