FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
K Number: K241039
·
Decision May 16, 2024
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
4
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
- K Number
- K241039
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reshape Lifesciences
- Date Received
- April 16, 2024
- Decision Date
- May 16, 2024
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology