Autoband Ligator
FDA 510(k) K132535 · Endochoice, Inc.
510(k) numberK132535
Submission
- Device name
- Autoband Ligator
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- August 13, 2013
- Decision date
- August 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MND
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083556 | Modification to Auto-Band LigatorMND · Special | Scandimed International | 02/19/2009SE |
| 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 |
| K013066 | HX-5/6-1 Endoscopic Clipping DeviceMND · Traditional | Olympus America, Inc. | 12/11/2001SE |
| 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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| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
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Questions and answers
When was Autoband Ligator cleared by the FDA?
Autoband Ligator (K132535) received a 510(k) decision of Substantially Equivalent on August 23, 2013, 10 days after the submission was received.
What is the product code of K132535?
The FDA product code is MND – Ligator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.