FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
K Number: K772121
·
Decision Nov 17, 1977
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
42
Review Days
7
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
- ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
- K Number
- K772121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- November 10, 1977
- Decision Date
- November 17, 1977
- 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.
Uterine Aspiration Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CrossGlide ETS Plus
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CrossBay Endometrial Tissue Sampler (ETS)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THE PANPAC SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Smithkline Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961062 | FLEXSURE OBT | Nov 6, 1996 | Substantially Equivalent |
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | Jun 7, 1996 | Substantially Equivalent |
| K934863 | FLEXSURE HP | May 18, 1994 | Substantially Equivalent |
| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Mar 1, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | Jul 24, 1985 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |