Medsurg Circumcision Tray
FDA 510(k) K920838 · Medsurg Industries, Inc.
510(k) numberK920838
Submission
- Device name
- Medsurg Circumcision Tray
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- February 24, 1992
- Decision date
- October 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFK – Mold, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3900
- Specialty
- Obstetrics/Gynecology
More from Medsurg Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | 08/19/1994SEKD |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | 05/26/1994SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | 03/28/1994SE |
| K925558 | InfiltubeHIF · Traditional | 03/04/1994SE |
| K934971 | Sterile Laparotomy SpongesGDY · Traditional | 02/07/1994SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | 12/13/1993SESK |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | 08/27/1993SEKD |
| K914037 | Medsurg O.R. Procedure TrayLRO · Traditional | 06/22/1993SEKD |
| K914036 | Medsurg Laparoscopy TrayLRO · Traditional | 03/18/1992SE |
| K893938 | Continuous Epidural Anesthesia TrayCAZ · Traditional | 08/07/1989SE |
Questions and answers
When was Medsurg Circumcision Tray cleared by the FDA?
Medsurg Circumcision Tray (K920838) received a 510(k) decision of Substantially Equivalent on October 15, 1993, 599 days after the submission was received.
What is the product code of K920838?
The FDA product code is HFK – Mold, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.