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510(k) K103155

SUMO ACCESS AND TISSUE RESECTION SYSTEM by Apollo Endosurgery, Inc. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2011
Date Received
October 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Apollo Endosurgery, Inc.

  • K232544 — Apollo ESG NXT System, Apollo REVISE NXT System (September 18, 2023)
  • K231553 — OverStitch NXT Endoscopic Suturing System (June 29, 2023)
  • DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX (July 12, 2022)
  • K210266 — OverStitch Sx Endoscopic Suturing System (March 2, 2021)
  • K201808 — X-Tack Endoscopic HeliX Tacking System (December 15, 2020)
  • K191439 — OverStitch 2-0 Polypropylene Suture (August 29, 2019)
  • K181141 — OverStitch Endoscopic Suturing System and Accessories (June 27, 2018)
  • K171886 — OverStitch SX Endoscopic Suturing System (ESS) (November 15, 2017)
  • K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEM (September 28, 2012)
  • K082102 — GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 (June 14, 2010)

Other clearances for product code ODC

  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)