Lofric Hydro-Kit II Single Use Urinary Catheter
FDA 510(k) K043241 · Astra Tech, Inc.
510(k) numberK043241
Submission
- Device name
- Lofric Hydro-Kit II Single Use Urinary Catheter
- Applicant
- Astra Tech, Inc.
Northborough, MA, US - Received
- November 23, 2004
- Decision date
- December 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K121810 | Osseospeed Angled Abutment EvNHA · Traditional | 01/23/2013SE |
| K122078 | Lofric Primo, Lofric Hydro-KitEZD · Traditional | 10/31/2012SE |
| K120414 | Osseospeed PlusDZE · Traditional | 07/31/2012SE |
| K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaNHA · Traditional | 07/05/2012SE |
| K113424 | Lofric Single Use Urinary CatheterEZD · Traditional | 04/17/2012SE |
| K113003 | Atlantis(Tm) Abutment and Atlantis(Tm) Crown Abutment for Keystone Genesis Implant…NHA · Traditional | 03/01/2012SE |
| K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantNHA · Traditional | 12/01/2011SE |
| K111287 | Astra Tech Implant SystemDZE · Traditional | 09/26/2011SE |
| K101005 | Astra Tech Implant System, New ComponentNHA · Special | 06/21/2011SE |
| K110640 | Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentNHA · Traditional | 06/10/2011SE |
Questions and answers
When was Lofric Hydro-Kit II Single Use Urinary Catheter cleared by the FDA?
Lofric Hydro-Kit II Single Use Urinary Catheter (K043241) received a 510(k) decision of Substantially Equivalent on December 23, 2004, 30 days after the submission was received.
What is the product code of K043241?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.