FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K Number: K801070
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
62
Review Days
76
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Basic Information
- Device Name
- SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
- K Number
- K801070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- May 6, 1980
- Decision Date
- July 21, 1980
- Product Code
- HHK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHK), ordered by most recent decision date.
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CrossGlide ETS Plus
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CrossBay Endometrial Tissue Sampler (ETS)
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DISPOSABLE ENDOMETRIAL SUCTION CURETTE
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FDA Class 2
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THE PANPAC SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |
| K772149 | LANCER BIOPSY HOLDER | Nov 22, 1977 | Substantially Equivalent |