FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
AG MASS
K Number: K131099
·
Decision May 13, 2013
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
6
Review Days
24
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
- AG MASS
- K Number
- K131099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitech Respiration , Ltd.
- Date Received
- April 19, 2013
- Decision Date
- May 13, 2013
- Product Code
- JCX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCX), ordered by most recent decision date.
Protable Phlegm Suction Unit (JMA D01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MV Flow Aspiration Pump (MVFLOWPMP01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cary
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Easycess Aspiration Pump
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Hospitech Respiration , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K221477 | AG100s | Dec 29, 2022 | Substantially Equivalent |
| K180991 | AG 100s | Oct 12, 2018 | Substantially Equivalent |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Feb 16, 2016 | Substantially Equivalent |
| K122721 | AG GUFFILL | May 3, 2013 | Substantially Equivalent |
| K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | Mar 2, 2010 | Substantially Equivalent |