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510(k) K210266

OverStitch Sx Endoscopic Suturing System by Apollo Endosurgery, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
February 1, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Tissue Approximation Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

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)
  • 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 OCW

  • K252400 — Endomina EZFuse system (February 13, 2026)
  • K243750 — SimpleStitch Suturing System (April 17, 2025)
  • K231240 — MaxTack™ Motorized Fixation Device (September 8, 2023)
  • K213271 — MedicloseTM System (August 31, 2023)
  • K231553 — OverStitch NXT Endoscopic Suturing System (June 29, 2023)
  • K211309 — endomina system (December 7, 2021)
  • K201744 — Su2ura Approximation Device (June 17, 2021)
  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
  • K191439 — OverStitch 2-0 Polypropylene Suture (August 29, 2019)
  • K181141 — OverStitch Endoscopic Suturing System and Accessories (June 27, 2018)