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510(k) K232544

Apollo ESG NXT System, Apollo REVISE NXT System by Apollo Endosurgery, Inc. — Product Code QTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2023
Date Received
August 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Device Class
Class II
Regulation Number
876.5983
Review Panel
GU
Submission Type

This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.

Other clearances by Apollo Endosurgery, Inc.

  • 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)
  • K103155 — SUMO ACCESS AND TISSUE RESECTION SYSTEM (October 28, 2011)
  • K082102 — GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 (June 14, 2010)

Other clearances for product code QTD

  • DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX (July 12, 2022)