FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROFLOW IRRIGATION SYSTEM
K Number: K941356
·
Decision May 19, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
7
Applicant Total
92
Review Days
59
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
- MICROFLOW IRRIGATION SYSTEM
- K Number
- K941356
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jedmed Instrument Co.
- Date Received
- March 21, 1994
- Decision Date
- May 19, 1994
- Product Code
- GBQ
- 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 |
|---|---|---|---|
| GBQ | Catheter, Continuous Irrigation | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBQ), ordered by most recent decision date.
CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GESCO CATHETERIZATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERFORATED SOAKING TUBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODIFIED CURLCATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GASTRIC LAVAGE KIT-DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Jedmed Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Feb 21, 2014 | Substantially Equivalent |
| K021750 | LID CHAIN EYELID WEIGHTS | Jan 27, 2003 | Substantially Equivalent |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | Nov 13, 1995 | Substantially Equivalent |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | Sep 15, 1995 | Substantially Equivalent |
| K950925 | JEDMED LARYNGEAL SCOPE | Aug 11, 1995 | Substantially Equivalent |
| K953457 | JEDMED SPECTRUM ENT CABINET | Aug 11, 1995 | Substantially Equivalent |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jun 28, 1995 | Substantially Equivalent |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jun 21, 1995 | Substantially Equivalent |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | Feb 7, 1995 | Substantially Equivalent |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Sep 23, 1994 | Substantially Equivalent |