Intrauterine Insemination Catheters
FDA 510(k) K896960 · C.R. Bard, Inc.
510(k) numberK896960
Submission
- Device name
- Intrauterine Insemination Catheters
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- December 14, 1989
- Decision date
- June 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDR – Cap, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01)HDR · Traditional | Stepone Fertility Ltd (T/A Béa Fertility) | 04/02/2025SE |
| K222969 | FERTI-LILY Conception CupHDR · Traditional | Rosesta Medical BV | 06/23/2023SE |
| K993953 | Oves Cervical CapHDR · Traditional | Veos , Ltd. | 03/21/2000SESU |
| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | Cook Urological, Inc. | 05/11/1995SE |
| K902171 | Minispace(Tm) Iui CatheterHDR · Traditional | Pharmacia, Inc. | 10/05/1990SE |
| K902694 | Coaxial Catheter SetHDR · Traditional | Cook Ob/Gyn | 08/28/1990SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | Irvine Scientific | 04/16/1990SE |
| K900308 | Sperm Select SystemHDR · Traditional | Pharmacia, Inc. | 04/13/1990SE |
| K900162 | DGH A-San Probe HolderHDR · Traditional | Jedmed Instrument Co. | 02/16/1990SE |
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| 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 Intrauterine Insemination Catheters cleared by the FDA?
Intrauterine Insemination Catheters (K896960) received a 510(k) decision of Substantially Equivalent on June 26, 1990, 194 days after the submission was received.
What is the product code of K896960?
The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.