Bard Eagle Inflation Device
FDA 510(k) K962611 · Ryder Intl. Corp.
510(k) numberK962611
Submission
- Device name
- Bard Eagle Inflation Device
- Applicant
- Ryder Intl. Corp.
Arab, AL, US - Received
- July 3, 1996
- Decision date
- October 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOE – Dilator, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation CatheterKOE · Traditional | Urotronic, Inc. | 01/02/2020SE |
| K032840 | Atrion Medical QL Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 03/03/2004SE |
| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 10/10/1997SE |
| K961904 | Aq Hydrophilic DilatorsKOE · Traditional | Cook Urological, Inc. | 10/18/1996SE |
| K924440 | U.S. Medical PS-7000 Dialysis ScaleKOE · Traditional | U.S. Medical Corp. | 05/26/1993SE |
| K920551 | 120 FR Optilume Prostate Balloon DilatorKOE · Traditional | American Medical Systems, Inc. | 10/28/1992SE |
| K922349 | Dowd(Tm) IIKOE · Traditional | Boston Scientific Corp | 08/14/1992SE |
| K920711 | Entrac Urethral Balloon Dilatation CatheterKOE · Traditional | American Medical Systems, Inc. | 05/06/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | Peripheral Systems Group | 12/27/1991SE |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | Advanced Surgical Intervention, Inc. | 08/27/1990SE |
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| K870278 | Contact Lens Case W/Postive Heat Indi. Mod. #695LPN · Traditional | 02/20/1987SE |
| K853727 | Kestrel Contact Lens Storage Case(Polysulfone)LRX · Traditional | 02/07/1986SE |
| K853729 | Kestrel Contact Lens Storage Case(Polystyrene)HPX · Traditional | 12/13/1985SE |
| K853728 | Kestrel Contact Lens Storage Case(Noryl)HPX · Traditional | 12/13/1985SE |
Questions and answers
When was Bard Eagle Inflation Device cleared by the FDA?
Bard Eagle Inflation Device (K962611) received a 510(k) decision of Substantially Equivalent on October 21, 1996, 110 days after the submission was received.
What is the product code of K962611?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.