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510(k) K082102

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 by Apollo Endosurgery, Inc. — Product Code FED

Clearance Details

Decision
SESU ()
Decision Date
June 14, 2010
Date Received
July 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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  • 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)

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  • K250585 — LumenaTM Ureteral Access Sheath (June 27, 2025)
  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K243710 — Disposable ureteral access sheath (April 11, 2025)
  • K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator (March 21, 2025)
  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)