Pattison Esophageal Dilator
FDA 510(k) K971615 · Tri-Med Specialties, Inc.
510(k) numberK971615
Submission
- Device name
- Pattison Esophageal Dilator
- Applicant
- Tri-Med Specialties, Inc.
Lenexa, KS, US - Received
- May 2, 1997
- Decision date
- July 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K970890 | #ES-32 Suction Catheter 32 Fr.KNT · Traditional | 05/23/1997SE |
| K970982 | T-Rx Retrieval ForcepsOCZ · Traditional | 05/09/1997SE |
| K942918 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 02/28/1995SE |
| K950574 | Needle/CannulaLRO · Traditional | 02/24/1995SEKD |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | 12/23/1994SE |
| K945160 | Paracentesis Needles/CannulasLRO · Traditional | 11/14/1994SE |
| K924549 | Tri-Med Quick-Step(Tm) Rectal TubeGBT · Traditional | 02/10/1994SE |
| K932015 | Tri-Med Inflatable Esophageal DilatorKNQ · Traditional | 02/03/1994SE |
| K932652 | Tri-Med Paracentesis TrayLRO · Traditional | 11/24/1993SEKD |
| K931201 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 09/28/1993SE |
Questions and answers
When was Pattison Esophageal Dilator cleared by the FDA?
Pattison Esophageal Dilator (K971615) received a 510(k) decision of Substantially Equivalent on July 24, 1997, 83 days after the submission was received.
What is the product code of K971615?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.