Hemorrhoidal Ligation Instr. System
FDA 510(k) K801352 · Depuy, Inc.
510(k) numberK801352
Submission
- Device name
- Hemorrhoidal Ligation Instr. System
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- June 9, 1980
- Decision date
- July 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K213223 | Multi-Band LigatorFHN · Traditional | Beijing Zksk Technology Co., Ltd. | 06/06/2022SE |
| K172985 | Ligation DeviceFHN · Traditional | Leo Medical Co., Ltd. | 06/14/2018SE |
| K150718 | Wi-3 HAL-RAR SystemFHN · Traditional | Agency For Medical Innovations GmbH | 06/12/2015SE |
| K131282 | Nexus Hemorrhoid LigatorFHN · Traditional | Inx Medical | 07/11/2013SE |
| 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 |
| K001236 | Riza Band Stretcher (RBS)-60000FHN · Traditional | R-Med, Inc. | 07/17/2000SE |
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Questions and answers
When was Hemorrhoidal Ligation Instr. System cleared by the FDA?
Hemorrhoidal Ligation Instr. System (K801352) received a 510(k) decision of Substantially Equivalent on July 8, 1980, 29 days after the submission was received.
What is the product code of K801352?
The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.