FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANAL/RECTAL SYRINGE
K Number: K761229
·
Decision Feb 24, 1977
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
14
Review Days
76
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Basic Information
- Device Name
- ANAL/RECTAL SYRINGE
- K Number
- K761229
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Ace Orthopedic Manufacturing Co.
- Date Received
- December 10, 1976
- Decision Date
- February 24, 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 |
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Other Clearances by Ace Orthopedic Manufacturing Co.
| K Number | Device Name | ||
|---|---|---|---|
| K934643 | ACE HUMERAL NAIL | Mar 22, 1994 | Substantially Equivalent |
| K934962 | AIM SUPRACONDYLAR NAIL | Mar 22, 1994 | Substantially Equivalent |
| K936045 | ACE UNILATERAL FIXATOR II | Feb 22, 1994 | Substantially Equivalent |
| K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | Mar 31, 1993 | Substantially Equivalent |
| K920738 | ACE 100 DEGREES TUBULAR PLATE | Jul 27, 1992 | Substantially Equivalent |
| K813554 | ACE/KYLE CAPTURED HIP SCREW | Jan 12, 1982 | Substantially Equivalent |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Mar 20, 1981 | Substantially Equivalent |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Sep 9, 1980 | Substantially Equivalent |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | Aug 16, 1979 | Substantially Equivalent |
| K781839 | BONE CLAMP, ACE EXTERNAL | Nov 8, 1978 | Substantially Equivalent |