Esophageal and Pyloric Balloon Dialators
FDA 510(k) K884712 · Primrose Medical, Inc.
510(k) numberK884712
Submission
- Device name
- Esophageal and Pyloric Balloon Dialators
- Applicant
- Primrose Medical, Inc.
Woburn, MA, US - Received
- November 8, 1988
- Decision date
- September 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNQ – Dilator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122924 | Cre Fixed Wire Ballon Dilation CatheterKNQ · Special | Boston Scientific Corp | 10/24/2012SE |
| K093236 | Ethicon Endo-Surgeryoptical DilatorKNQ · Special | Ethicon Endo-Surgery, Inc. | 11/10/2009SE |
| K090183 | Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special | Cook Endoscopy | 09/25/2009SE |
| K082995 | Smart DilatorKNQ · Traditional | Safestitch Medical | 02/06/2009SE |
| K061937 | Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional | Cook Endoscopy | 12/01/2006SE |
| K061787 | Maxforce TTS Single-Use Balloon DilatorKNQ · Traditional | Boston Scientific Corp | 09/21/2006SE |
| K060302 | Inscope Precision Balloon Dilator - Wire GuidedKNQ · Traditional | Cordis Europa, N.V. | 04/11/2006SE |
| K043605 | Inscope 3-STAGE Balloon DilatorKNQ · Traditional | Cordis Europa, N.V. | 02/04/2005SE |
| K033936 | Bard Eliminator PET Balloon DilatorsKNQ · Special | C.R. Bard, Inc. | 01/14/2004SE |
| K031147 | Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional | Ethicon Endo-Surgery, Inc. | 01/12/2004SE |
More from Ethicon Endo-Surgery, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884715 | Achelasia Balloon DialatorKNQ · Traditional | 09/29/1989SE |
| K884714 | Biliary DialatorFGE · Traditional | 09/29/1989SE |
| K884713 | Colonic Balloon DialatorsFFP · Traditional | 09/29/1989SE |
| K884711 | Urethral and Ureteral Balloon DilatatorsEZN · Traditional | 09/29/1989SE |
| K884709 | Endoscopes & Access.(Sclerotherapy/Transbronchial)ODD · Traditional | 09/08/1989SE |
| K883420 | Lancet, BloodFMK · Traditional | 08/26/1988SE |
| K881976 | Catheter, IntravascularFOZ · Traditional | 08/04/1988SE |
| K881977 | Pressure InfusorKZD · Traditional | 07/29/1988SE |
| K881975 | Set, IntravascularFPA · Traditional | 07/29/1988SE |
| K881978 | Enteral Feeding TubesKNT · Traditional | 07/13/1988SE |
Questions and answers
When was Esophageal and Pyloric Balloon Dialators cleared by the FDA?
Esophageal and Pyloric Balloon Dialators (K884712) received a 510(k) decision of Substantially Equivalent on September 8, 1989, 304 days after the submission was received.
What is the product code of K884712?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.