FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Gastro Concepts Air Assist
K Number: K242668
·
Decision Dec 13, 2024
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
1
Review Days
99
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
- Gastro Concepts Air Assist
- K Number
- K242668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gastro Concepts, LLC
- Date Received
- September 5, 2024
- Decision Date
- December 13, 2024
- Product Code
- FER
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FER), ordered by most recent decision date.
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WellCare Anoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Applied Medical Anoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GelPOINT Path Transanal Access Platform
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GELPOINT PATH TRANSANAL ACCESS PLATFORM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THD N-ANO ANOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology