FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOTTLE COLLECTION SET
K Number: K945179
·
Decision Jan 26, 1995
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
5
Review Days
94
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
- BOTTLE COLLECTION SET
- K Number
- K945179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medgyn Products, Inc.
- Date Received
- October 24, 1994
- Decision Date
- January 26, 1995
- Product Code
- HGF
- 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 |
|---|---|---|---|
| HGF | Source, Abortion Unit, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGF), ordered by most recent decision date.
BIOVISION ENDOCULAR PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODEL GLASE 210 HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
O-020 LASER INDIRECT OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medgyn Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | Nov 23, 2015 | Substantially Equivalent |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Jun 12, 2013 | Substantially Equivalent |
| K880196 | LAMINARIA | May 6, 1988 | Substantially Equivalent |
| K880195 | GYNESCOPE | Mar 14, 1988 | Substantially Equivalent |