Maxi-Flow Insufflator Tubing Set W/Filter
FDA 510(k) K903209 · Adler Instrument Co.
510(k) numberK903209
Submission
- Device name
- Maxi-Flow Insufflator Tubing Set W/Filter
- Applicant
- Adler Instrument Co.
Norcross, GA, US - Received
- July 20, 1990
- Decision date
- December 21, 1990
- 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 |
| 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 |
More from Cabot Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K910171 | Maxi-Flow Suction Set W/Y ConnectorGAZ · Traditional | 02/01/1991SE |
| K910170 | Maxi-Flow Suction Set 12 Ft.GAZ · Traditional | 02/01/1991SE |
| K903208 | Maxi-Flow Insufflator Tubing SetHES · Traditional | 12/17/1990SE |
| K900913 | Adler Disposable Bipolar CordHQO · Traditional | 04/04/1990SE |
| K841723 | Adler Custom Procedure Packs · Traditional | 08/01/1984SE |
| K833264 | Adler Steam Indicator-Gas IndicatorJOJ · Traditional | 11/03/1983SE |
| K831068 | Container System · Traditional | 05/09/1983SE |
Questions and answers
When was Maxi-Flow Insufflator Tubing Set W/Filter cleared by the FDA?
Maxi-Flow Insufflator Tubing Set W/Filter (K903209) received a 510(k) decision of Substantially Equivalent on December 21, 1990, 154 days after the submission was received.
What is the product code of K903209?
The FDA product code is HES – Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1300.