Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula
FDA 510(k) K140761 · Carefusion 2200, Inc.
510(k) numberK140761
Submission
- Device name
- Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula
- Applicant
- Carefusion 2200, Inc.
Vernon Hills, IL, US - Received
- March 26, 2014
- Decision date
- April 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K890869 | Bard Hysterosalpingography CathetersHES · Traditional | C.R. Bard, Inc. | 04/25/1989SE |
| 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 |
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| K142529 | Genesis Reusable Rigid Container SystemKCT · Traditional | 01/08/2015SE |
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Questions and answers
When was Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula cleared by the FDA?
Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula (K140761) received a 510(k) decision of Substantially Equivalent on April 21, 2014, 26 days after the submission was received.
What is the product code of K140761?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.