Sumo Access and Tissue Resection System
FDA 510(k) K103155 · Apollo Endosurgery, Inc.
510(k) numberK103155
Submission
- Device name
- Sumo Access and Tissue Resection System
- Applicant
- Apollo Endosurgery, Inc.
Austin, TX, US - Received
- October 26, 2010
- Decision date
- October 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K082102 | Gastric Port, Models: GAP-0016-00, GAP-0018-00, GAP-0020-00FED · Traditional | 06/14/2010SESU |
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Questions and answers
When was Sumo Access and Tissue Resection System cleared by the FDA?
Sumo Access and Tissue Resection System (K103155) received a 510(k) decision of Substantially Equivalent on October 28, 2011, 367 days after the submission was received.
What is the product code of K103155?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.