Kolster Methods
FDA 510(k) K935820 · Kolster Methods
510(k) numberK935820
Submission
- Device name
- Kolster Methods
- Applicant
- Kolster Methods
Anaheim, CA, US - Received
- December 3, 1993
- Decision date
- July 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGH – Cannula, Suction, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172151 | Hysteroscopy SystemHGH · Traditional | Chongquin Jinshan Science & Technology (Group)… | 04/09/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | Panpac Medical Corporation | 01/13/2017SE |
| K140213 | Disposable Endoscopic CannulaHGH · Traditional | Dongguan Microview Medical Technology Co., Ltd. | 03/25/2015SE |
| K093508 | Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)HGH · Traditional | Womancare Global | 03/04/2010SE |
| K840285 | Non Stress Test Monitor 507HGH · Traditional | Imex Medical Systems, Inc. | 05/09/1984SE |
More from Imex Medical Systems, Inc.
Questions and answers
When was Kolster Methods cleared by the FDA?
Kolster Methods (K935820) received a 510(k) decision of Substantially Equivalent on July 19, 1994, 228 days after the submission was received.
What is the product code of K935820?
The FDA product code is HGH – Cannula, Suction, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.5070.