FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FINE NEEDLE ASPIRATION DEVICE
K Number: K841275
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
5
Review Days
143
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Basic Information
- Device Name
- FINE NEEDLE ASPIRATION DEVICE
- K Number
- K841275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gyneco, Inc.
- Date Received
- March 27, 1984
- Decision Date
- August 17, 1984
- Product Code
- DRM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | FDA class 2 | Cardiovascular |
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Other Clearances by Gyneco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861409 | SYNCARE TEMPORARY CARDIAC PACING WIRE | May 5, 1986 | Substantially Equivalent |
| K853216 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 | Apr 2, 1986 | Substantially Equivalent |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Jul 5, 1985 | Substantially Equivalent |
| K843941 | ENDOCYTE | Feb 25, 1985 | Substantially Equivalent |