Riza Band Stretcher (RBS)-60000
FDA 510(k) K001236 · R-Med, Inc.
510(k) numberK001236
Submission
- Device name
- Riza Band Stretcher (RBS)-60000
- Applicant
- R-Med, Inc.
Oregon, OH, US - Received
- April 18, 2000
- Decision date
- July 17, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FHN – Ligator, Hemorrhoidal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
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| K150718 | Wi-3 HAL-RAR SystemFHN · Traditional | Agency For Medical Innovations GmbH | 06/12/2015SE |
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| K093497 | THD BandyFHN · Traditional | Thd Spa | 07/15/2010SE |
| K091519 | Haemoband Multi-LigatorFHN · Traditional | Haemoband Surgical, Ltd. | 07/28/2009SE |
| K070881 | Lem Hemorrhoidal Ligator, Models A.5650, A.5660FHN · Traditional | Sapimed S.P.A. | 09/26/2007SE |
| K020824 | Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238FHN · Special | Boston Scientific Corp | 04/12/2002SE |
| K020526 | Modification to Wilson-Cook Multiple Band LigatorFHN · Special | Don Wilson/Wilson-Cook Medical, Inc. | 03/19/2002SE |
| K000297 | Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod.…FHN · Traditional | Erchinger Medizintecnik | 04/24/2000SE |
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| K953360 | R-Med Abdominal Wall ElevatorHET · Traditional | 01/11/1996SE |
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| K953441 | Riza-Ribe NeedleFBK · Traditional | 08/18/1995SE |
| K950108 | R-Med Mini-RetractorHET · Traditional | 05/11/1995SE |
| K942411 | R-Med Disposable PlugHET · Traditional | 03/31/1995SE |
| K945637 | R-Med Motorized Laparoscopic HandleGCJ · Traditional | 12/07/1994SE |
| K943818 | Manual Laparosopic Handle, Interchangeable Laparoscopic Tool UnitsGEI · Traditional | 08/29/1994SE |
| K935031 | Riza-Ribe NeedleHET · Traditional | 04/25/1994SE |
Questions and answers
When was Riza Band Stretcher (RBS)-60000 cleared by the FDA?
Riza Band Stretcher (RBS)-60000 (K001236) received a 510(k) decision of Substantially Equivalent on July 17, 2000, 90 days after the submission was received.
What is the product code of K001236?
The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.