Bard Ultraview Multiple Band Ligator, Model 00700U
FDA 510(k) K033245 · C.R. Bard, Inc.
510(k) numberK033245
Submission
- Device name
- Bard Ultraview Multiple Band Ligator, Model 00700U
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- October 7, 2003
- Decision date
- November 6, 2003
- 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
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| K083556 | Modification to Auto-Band LigatorMND · Special | Scandimed International | 02/19/2009SE |
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| K031236 | Auto-Band LigatorMND · Traditional | Scandimed. A.S. | 11/14/2003SE |
| 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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Questions and answers
When was Bard Ultraview Multiple Band Ligator, Model 00700U cleared by the FDA?
Bard Ultraview Multiple Band Ligator, Model 00700U (K033245) received a 510(k) decision of Substantially Equivalent on November 6, 2003, 30 days after the submission was received.
What is the product code of K033245?
The FDA product code is MND – Ligator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.