Cabot Medical Variable Flow Insufflator
FDA 510(k) K862310 · Cabot Medical Corp.
510(k) numberK862310
Submission
- Device name
- Cabot Medical Variable Flow Insufflator
- Applicant
- Cabot Medical Corp.
Langhorne, PA, US - Received
- June 17, 1986
- Decision date
- August 12, 1986
- 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K960148 | Circon-Surgitek Classic Double Pigtail Ureteral StentFAD · Traditional | 03/25/1996SE |
| K946109 | Cabot Medical Reusable Bipolar Cutting ForcepsKNS · Traditional | 11/21/1995SE |
| K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsFBO · Traditional | 07/21/1995SE |
| K951714 | Cabot Medical-Surgitek Ultragold Plus Side-Firing Urologic Laser FiberGEX · Traditional | 07/11/1995SE |
| K941743 | Cabot Medical Niagara Fluid Management PumpHIG · Traditional | 04/19/1995SE |
| K934115 | 3000 Electronic Insufflator ModificationHIF · Traditional | 03/15/1995SE |
| K932293 | Cabot Medical Bipolar Cutting ForcepsKNS · Traditional | 07/27/1994SE |
| K930954 | The Cabot Medical Insul-Sheth Vaginal Speculum CovHIB · Traditional | 06/30/1994SE |
| K932626 | Cabot Medical Surgiflex(R) Suction-Irrigation ProbGCJ · Traditional | 06/08/1994SE |
| K935786 | Corson and Nezhat Suction/Irrigation ProbesGCJ · Traditional | 05/19/1994SE |
Questions and answers
When was Cabot Medical Variable Flow Insufflator cleared by the FDA?
Cabot Medical Variable Flow Insufflator (K862310) received a 510(k) decision of Substantially Equivalent on August 12, 1986, 56 days after the submission was received.
What is the product code of K862310?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.