FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INJECTION ASPIRATING NEEDLES
K Number: K821697
·
Decision Jun 25, 1982
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
19
Review Days
17
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Basic Information
- Device Name
- INJECTION ASPIRATING NEEDLES
- K Number
- K821697
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Endoscopy, Inc.
- Date Received
- June 8, 1982
- Decision Date
- June 25, 1982
- 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 |
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Other Clearances by American Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853274 | AMERICAN DILATATION SYSTEM | Oct 17, 1985 | Substantially Equivalent |
| K841384 | PROXIMA 1 PH MONITOR | Jul 19, 1984 | Substantially Equivalent |
| K833491 | ENDO BITE BLOCK | Apr 25, 1984 | Substantially Equivalent |
| K840818 | BIOPSY FORCEPS | Apr 13, 1984 | Substantially Equivalent |
| K833859 | TAMPONADE BALLOON CUFF | Jan 3, 1984 | Substantially Equivalent |
| K833492 | PERCUTANEOUS ENDOSCOPIC GASTROSCOPY | Nov 29, 1983 | Substantially Equivalent |
| K832458 | AUTOMATIC ENDOSCOPE | Oct 20, 1983 | Substantially Equivalent |
| K821818 | RETRIEVAL BALLOONS | Sep 24, 1982 | Substantially Equivalent |
| K821819 | PIGTAIL STENTS | Aug 20, 1982 | Substantially Equivalent |
| K822062 | BALL TIP COAGULATING ELECTRODES | Aug 19, 1982 | Substantially Equivalent |