FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REDDICK IRRIGATION/ASPIRATION SYSTEM
K Number: K910117
·
Decision Mar 19, 1991
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
16
Review Days
67
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
- REDDICK IRRIGATION/ASPIRATION SYSTEM
- K Number
- K910117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ideal Medical, Inc.
- Date Received
- January 11, 1991
- Decision Date
- March 19, 1991
- Product Code
- GAA
- 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 |
|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAA), ordered by most recent decision date.
CapnoSpot Pneumothorax Decompression Indicator
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANAN ACCURA NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Ideal Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944067 | PEANUT WAND, MODIFICATION | Dec 8, 1994 | Substantially Equivalent |
| K931115 | HATCHER STONE-EMBOLIS EXTRACTOR | Aug 20, 1993 | Substantially Equivalent |
| K926335 | IDEAS PEANUT WAND | Jun 24, 1993 | Substantially Equivalent |
| K922161 | GRICE SOFT TISSUE BIOPSY KIT | Oct 13, 1992 | Substantially Equivalent |
| K921922 | GRICE LAPAROSCOPIC SUTURING NEEDLE | Jul 8, 1992 | Substantially Equivalent |
| K915175 | REDDICK RETRACTOR | Apr 29, 1992 | Substantially Equivalent |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | Mar 16, 1992 | Substantially Equivalent |
| K913602 | IDEAS' PORT | Jan 2, 1992 | Unknown |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Dec 31, 1991 | Substantially Equivalent |
| K912540 | CONTOUR-PORT | Aug 23, 1991 | Unknown |