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510(k) K110829

ACE STAPLER AND CARTRIDGE by Barosense, Inc. — Product Code OCW

K110829 is an FDA 510(k) premarket notification submitted by Barosense, Inc. for the device "ACE STAPLER AND CARTRIDGE". The FDA issued a decision of Substantially Equivalent on June 3, 2011. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Barosense, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2011
Date Received
March 24, 2011
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 Barosense, Inc.

  • K120126 — BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE (September 10, 2012)
  • K120147 — ACE STAPLER AND CARTRIDGE (February 17, 2012)
  • K082044 — ACE STAPLER, MODEL F0031 (May 11, 2010)
  • K082589 — BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 (May 22, 2009)

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)
  • 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)

FDA data resources