Circumcision Tray
FDA 510(k) K935697 · Cush Medical Products
510(k) numberK935697
Submission
- Device name
- Circumcision Tray
- Applicant
- Cush Medical Products
Piney Flats, TN, US - Received
- November 30, 1993
- Decision date
- May 2, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFX – Clamp, Circumcision
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | Medline Industries, LP | 02/25/2026SE |
| K221356 | Wee BellHFX · Traditional | Wee Medical | 02/02/2023SE |
| K212911 | Konig Mogen ClampHFX · Traditional | Medline Industries, Inc. | 11/18/2022SE |
| K151095 | Circumplast Circumcision DeviceHFX · Traditional | Novadien Healthcare | 09/18/2015SE |
| K142163 | Male Circumcision Kits:RapideclampHFX · Traditional | Medicfit Technology Sdn Bhd | 04/20/2015SE |
| K131373 | ShangringHFX · Special | Wuhu Snnda Medical Treatment Appliance Technology | 06/25/2013SE |
| K121789 | ShangringHFX · Traditional | Wuhu Snna Medical Treatment Appliance Technology C | 08/03/2012SE |
| K103695 | Prepex SystemHFX · Traditional | Circ Medtech | 01/10/2012SE |
| K100916 | Medicon Mogen ClampHFX · Traditional | Medicon EG | 12/06/2010SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | Clinical Innovations, LLC | 09/20/2007SE |
More from Clinical Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K943424 | Cush Island DressingMGP · Traditional | 10/03/1994SN |
| K940518 | C-Section TrayMLS · Traditional | 08/18/1994SEKD |
| K941349 | Dental TrayEIA · Traditional | 07/26/1994SN |
| K941645 | Biopsy TrayFRG · Traditional | 07/14/1994SEKD |
| K940239 | Eye TrayLRP · Traditional | 06/28/1994SEKD |
| K935684 | IV Start KitLRS · Traditional | 06/10/1994SEKD |
| K941455 | Sterile Gauze Product LineEFQ · Traditional | 05/20/1994SESK |
| K941522 | Sterile X-Ray Detectable Gauze SpongesGDY · Traditional | 05/12/1994SE |
| K941344 | Lap Sponge Product LineGDY · Traditional | 05/12/1994SE |
| K936120 | Labor and Delivery TrayMLS · Traditional | 03/30/1994SEKD |
Questions and answers
When was Circumcision Tray cleared by the FDA?
Circumcision Tray (K935697) received a 510(k) decision of Unknown on May 2, 1994, 153 days after the submission was received.
What is the product code of K935697?
The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.