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510(k) K012411

HP-ONE by Gi Supply — Product Code LYR

K012411 is an FDA 510(k) premarket notification submitted by Gi Supply for the device "HP-ONE". The FDA issued a decision of Substantially Equivalent on September 25, 2001. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Gi Supply has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2001
Date Received
July 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Gi Supply

  • K221042 — Renova RP Centesis Pump (April 19, 2023)
  • K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
  • K191923 — EverLift Submucosal Lifting Agent (June 20, 2020)
  • K031360 — GI SUPPLY BILIARY STENT (September 24, 2003)
  • K970186 — GI SUPPLY PARACENTESIS PUMP (February 14, 1997)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)
  • K944903 — HP-FAST (April 20, 1995)
  • K931044 — OXY-BLOC (October 4, 1993)
  • K915816 — BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY (March 27, 1992)

Other clearances for product code LYR

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)

FDA data resources