HX-5/6-1 Endoscopic Clipping Device
FDA 510(k) K013066 · Olympus America, Inc.
510(k) numberK013066
Submission
- Device name
- HX-5/6-1 Endoscopic Clipping Device
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- September 12, 2001
- Decision date
- December 11, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MND – Ligator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
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| K081142 | Auto-Band LigatorMND · Special | Scandimed International | 05/16/2008SE |
| K051950 | Inscope Multi-Clip Applier, Models IN22321, IN23321MND · Traditional | Ethicon Endo-Surgery, Inc. | 10/07/2005SE |
| K031236 | Auto-Band LigatorMND · Traditional | Scandimed. A.S. | 11/14/2003SE |
| K033245 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Special | C.R. Bard, Inc. | 11/06/2003SE |
| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Traditional | C.R. Bard, Inc. | 08/05/2002SE |
| K001744 | Olympus Endoscopic Ligation DeviceMND · Traditional | Olympus America, Inc. | 02/27/2001SE |
| K990864 | Speedband Superview Multiple Band Ligator, Models 4225, 4228MND · Traditional | Boston Scientific Corp | 06/11/1999SE |
| K984255 | Olympus HX-20 Series Ligating DeviceMND · Traditional | Olympus Corp of America | 01/12/1999SE |
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Questions and answers
When was HX-5/6-1 Endoscopic Clipping Device cleared by the FDA?
HX-5/6-1 Endoscopic Clipping Device (K013066) received a 510(k) decision of Substantially Equivalent on December 11, 2001, 90 days after the submission was received.
What is the product code of K013066?
The FDA product code is MND – Ligator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.