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510(k) K082044

ACE STAPLER, MODEL F0031 by Barosense, Inc. — Product Code OCW

K082044 is an FDA 510(k) premarket notification submitted by Barosense, Inc. for the device "ACE STAPLER, MODEL F0031". The FDA issued a decision of Substantially Equivalent on May 11, 2010. 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
May 11, 2010
Date Received
July 18, 2008
Clearance Type
Traditional
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)
  • K110829 — ACE STAPLER AND CARTRIDGE (June 3, 2011)
  • 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