Asi Hemostasis Catheter
FDA 510(k) K901336 · Advanced Surgical Intervention, Inc.
510(k) numberK901336
Submission
- Device name
- Asi Hemostasis Catheter
- Applicant
- Advanced Surgical Intervention, Inc.
San Clemente, CA, US - Received
- March 22, 1990
- Decision date
- June 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
More from Hollister Incorporated
| 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 |
| K896713 | Asi Tcu Prostatic Urethroplasty Catheter & Access.KOE · Traditional | 05/24/1990SE |
| 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 Hemostasis Catheter cleared by the FDA?
Asi Hemostasis Catheter (K901336) received a 510(k) decision of Substantially Equivalent on June 20, 1990, 90 days after the submission was received.
What is the product code of K901336?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.