Dex-Cell Hysteroscopy Fluid Delivery Device
FDA 510(k) K892001 · Dexide, Inc.
510(k) numberK892001
Submission
- Device name
- Dex-Cell Hysteroscopy Fluid Delivery Device
- Applicant
- Dexide, Inc.
Fort Worth, TX, US - Received
- March 28, 1989
- Decision date
- June 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261706 | Endomat Select (UP220)HIG · Traditional | Karl Storz Se & Co. KG | 07/16/2026SE |
| K251273 | Asurys Fluid Management SystemHIG · Traditional | Boston Scientific Corporation | 03/27/2026SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | Hologic, Inc. | 07/25/2024SE |
| K210628 | X-FLO Fluid Management SystemHIG · Traditional | Thermedx, LLC | 11/04/2021SE |
| K201355 | Endomat Select, IBS Shaver Software, LicenseHIG · Special | Karl Storz SE & CO. KG | 07/22/2020SE |
| K180735 | Endomat SelectHIG · Traditional | Karl Storz SE & CO. KG | 10/31/2018SE |
| K180825 | Fluent Fluid Management SystemHIG · Traditional | Hologic, Inc. | 08/03/2018SE |
| K173489 | GYN-Pump PH304HIG · Traditional | W.O.M. World of Medicine GmbH | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | W.O.M. World of Medicine GmbH | 02/05/2018SE |
| K172048 | FluidSmartHIG · Special | Thermedx, LLC | 09/05/2017SE |
More from Thermedx, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K991814 | Multachoice InstrumentsGEI · Special | 06/23/1999SE |
| K990379 | Modification to Multaport Cannula, Reducer and AccessoriesGCJ · Special | 03/04/1999SE |
| K981940 | Multapump Disposable Pump Head and AccessoriesGCJ · Traditional | 09/25/1998SE |
| K981941 | Multaport Cannula Reducer and AccessoriesGCJ · Traditional | 07/29/1998SE |
| K953611 | Dexide Endo-Lube KitGCJ · Traditional | 09/15/1995SE |
| K944509 | Dexide Insufflation Tubing with FilterHIF · Traditional | 02/07/1995SE |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | 03/23/1993SESK |
| K923845 | Dexide Laparoscopic AccessoriesGEI · Traditional | 11/25/1992SE |
| K921709 | Endobag, ModificationGCJ · Traditional | 07/14/1992SE |
| K913762 | Monoscopy(Tm) Brand, EndobagGCJ · Traditional | 10/28/1991SE |
Questions and answers
When was Dex-Cell Hysteroscopy Fluid Delivery Device cleared by the FDA?
Dex-Cell Hysteroscopy Fluid Delivery Device (K892001) received a 510(k) decision of Substantially Equivalent on June 16, 1989, 80 days after the submission was received.
What is the product code of K892001?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.