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510(k) K051919

MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE by Usgi Medical — Product Code FED

K051919 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE". The FDA issued a decision of Substantially Equivalent on July 26, 2005. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Usgi Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2005
Date Received
July 15, 2005
Clearance Type
Special
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.

Other clearances by Usgi Medical

  • K103688 — G-PROX EZ ENDOSCOPIC GRASPER (January 14, 2011)
  • K102931 — G-CINCH SUTURE GRASPER (December 30, 2010)
  • K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER (October 20, 2010)
  • K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 (February 17, 2010)
  • K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 205333 (October 7, 2009)
  • K072405 — USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (September 13, 2007)
  • K061276 — G-PROX ENDOSCOPIC GRASPER (December 6, 2006)
  • K061268 — G-LIX TISSUE GRASPER (July 31, 2006)
  • K061216 — USGI TRANSPORT ENDOSCOPIC GUIDE (May 15, 2006)
  • K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE (February 28, 2005)

Other clearances for product code FED

  • K260965 — CVAC Aspiration System (April 13, 2026)
  • K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100- (April 6, 2026)
  • K252572 — Prodeon Urethral Sheath System (October 7, 2025)
  • K250128 — Single Use Suction-Evacuation Ureteral Access Sheath (September 19, 2025)
  • K250132 — Ureteral Access Sheath (September 5, 2025)
  • K250695 — Single-use Ureteral Access Sheath (July 8, 2025)
  • K251599 — Single-use Ureteral Access Sheath (July 3, 2025)
  • 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)

FDA data resources