SUMO ACCESS AND TISSUE RESECTION SYSTEM— 510(k) K103155
Substantially EquivalentApollo Endosurgery, Inc.
FDA 510(k) clearance K103155 for SUMO ACCESS AND TISSUE RESECTION SYSTEM, Substantially Equivalent on 2011-10-28. Applicant: Apollo Endosurgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Apollo Endosurgery, Inc.
- Product code
- Code ODC
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code ODC
view allMore clearances from Apollo Endosurgery, Inc.
view all- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- K231553 — OverStitch NXT Endoscopic Suturing System
- DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- K210266 — OverStitch Sx Endoscopic Suturing System
- K201808 — X-Tack Endoscopic HeliX Tacking System
Data sourced from openFDA. This site is unofficial and independent of the FDA.