Bottle Collection Set
FDA 510(k) K945179 · Medgyn Products, Inc.
510(k) numberK945179
Submission
- Device name
- Bottle Collection Set
- Applicant
- Medgyn Products, Inc.
Lombard, IL, US - Received
- October 24, 1994
- Decision date
- January 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGF – Source, Abortion Unit, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905115 | Biovision Endocular ProbeHGF · Traditional | Douglas James Donaldson Compliance Services | 02/11/1991SE |
| K904248 | Model Glase 210 Holmium Laser SystemHGF · Traditional | Charles L. Rose and Co., Inc. | 12/14/1990SE |
| K890787 | O-020 Laser Indirect OphthalmoscopeHGF · Traditional | Hgm Medical Laser Systems, Inc. | 03/24/1989SE |
More from Hgm Medical Laser Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterMQF · Traditional | 11/23/2015SE |
| K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeHEX · Traditional | 06/12/2013SE |
| K880196 | LaminariaHDY · Traditional | 05/06/1988SE |
| K880195 | GynescopeHEX · Traditional | 03/14/1988SE |
Questions and answers
When was Bottle Collection Set cleared by the FDA?
Bottle Collection Set (K945179) received a 510(k) decision of Substantially Equivalent on January 26, 1995, 94 days after the submission was received.
What is the product code of K945179?
The FDA product code is HGF – Source, Abortion Unit, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.