Bard Hysterosalpingography Catheters
FDA 510(k) K890869 · C.R. Bard, Inc.
510(k) numberK890869
Submission
- Device name
- Bard Hysterosalpingography Catheters
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- February 21, 1989
- Decision date
- April 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140761 | Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian CannulaHES · Special | Carefusion 2200, Inc. | 04/21/2014SE |
| K000340 | Hystalog HSG CatheterHES · Traditional | Rocket Medical Plc | 04/19/2000SE |
| K903209 | Maxi-Flow Insufflator Tubing Set W/FilterHES · Traditional | Adler Instrument Co. | 12/21/1990SE |
| K903208 | Maxi-Flow Insufflator Tubing SetHES · Traditional | Adler Instrument Co. | 12/17/1990SE |
| K904473 | Kronner ManipujectorHES · Traditional | Unimar, Inc. | 12/14/1990SE |
| K901413 | Core Disposable Insufflation TubingHES · Traditional | Core Dynamics, Inc. | 09/24/1990SE |
| K891290 | Sholkoff Balloon Hysterosalpingography CatheterHES · Traditional | Cook Ob/Gyn | 05/23/1989SE |
| K875137 | Laparoflator 3000, Standard and ElectronicHES · Traditional | F.M. Wiest USA, Inc. | 03/02/1988SE |
| K873515 | Uterine Injector 2MMHES · Traditional | Zinnanti Surgical Instruments, Inc. | 09/29/1987SE |
| K862310 | Cabot Medical Variable Flow InsufflatorHES · Traditional | Cabot Medical Corp. | 08/12/1986SE |
More from Cabot Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Bard Hysterosalpingography Catheters cleared by the FDA?
Bard Hysterosalpingography Catheters (K890869) received a 510(k) decision of Substantially Equivalent on April 25, 1989, 63 days after the submission was received.
What is the product code of K890869?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.