FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYRINGE, IRRIGATION, PRE-FILLED
K Number: K772134
·
Decision Nov 28, 1977
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
14
Review Days
14
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
- SYRINGE, IRRIGATION, PRE-FILLED
- K Number
- K772134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Kendall Research Center
- Date Received
- November 14, 1977
- Decision Date
- November 28, 1977
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOA), ordered by most recent decision date.
FiXcision
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URETHRAL SUTURE GUIDE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LI VASECTOMY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VASOVASOSTOMY SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VESITEC SUTURE PASSER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DDV LIGATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Kendall Research Center
| K Number | Device Name | ||
|---|---|---|---|
| K802225 | TENDER-SORB DRAIN SPONGES | Sep 26, 1980 | Substantially Equivalent |
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | Sep 20, 1978 | Substantially Equivalent |
| K780408 | MICRONET LIGHT DRESSING SPONGE | Mar 22, 1978 | Substantially Equivalent |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC | Feb 14, 1978 | Substantially Equivalent |
| K780120 | ANESTHESIA TRAY, CAUDAL | Feb 6, 1978 | Substantially Equivalent |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Nov 28, 1977 | Substantially Equivalent |
| K771655 | CURITY PEAKOMETER | Oct 14, 1977 | Substantially Equivalent |
| K771079 | CURITY IRRIGATION TRAY | Sep 15, 1977 | Substantially Equivalent |
| K771452 | CONFORM STRETCH BANDAGE (5SIZES) | Sep 12, 1977 | Substantially Equivalent |
| K771563 | CONFORM ELASTIC NETTING | Sep 12, 1977 | Substantially Equivalent |