Asi Tcu Prostatic Urethroplasty Catheter & Access.
FDA 510(k) K896713 · Advanced Surgical Intervention, Inc.
510(k) numberK896713
Submission
- Device name
- Asi Tcu Prostatic Urethroplasty Catheter & Access.
- Applicant
- Advanced Surgical Intervention, Inc.
San Clemente, CA, US - Received
- November 29, 1989
- Decision date
- May 24, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOE – Dilator, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K962611 | Bard Eagle Inflation DeviceKOE · Traditional | Ryder Intl. Corp. | 10/21/1996SE |
| 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 |
More from Peripheral Systems Group
| 510(k) | Device | Decision |
|---|---|---|
| K954215 | MiniguardMNG · Traditional | 05/08/1996SE |
| K926110 | Asi Ligasure(Tm) Suture Ligation InstrumentGCJ · Traditional | 07/08/1993SE |
| K930361 | Asi Cystolase Laser CystoscopeGEX · Traditional | 04/29/1993SE |
| K921990 | Asi Uroplasty Laser CystoscopeGEX · Traditional | 10/28/1992SE |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | 08/27/1990SE |
| K901336 | Asi Hemostasis CatheterGBM · Traditional | 06/20/1990SE |
| K895182 | Asi Cystoscope Sheath, Grasping Forceps & For.BodyFAJ · Traditional | 10/24/1989SE |
| K874530 | Urethral Dilator EndoscopeKOB · Traditional | 01/27/1988SE |
Questions and answers
When was Asi Tcu Prostatic Urethroplasty Catheter & Access. cleared by the FDA?
Asi Tcu Prostatic Urethroplasty Catheter & Access. (K896713) received a 510(k) decision of Substantially Equivalent on May 24, 1990, 176 days after the submission was received.
What is the product code of K896713?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.