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510(k) K231553

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

K231553 is an FDA 510(k) premarket notification submitted by Apollo Endosurgery, Inc. for the device "OverStitch NXT Endoscopic Suturing System". The FDA issued a decision of Substantially Equivalent on June 29, 2023. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Apollo Endosurgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
May 30, 2023
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)
  • 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 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)
  • K211309 — endomina system (December 7, 2021)
  • K201744 — Su2ura Approximation Device (June 17, 2021)
  • K210266 — OverStitch Sx Endoscopic Suturing System (March 2, 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)

FDA data resources