510(k) Report

FDA applicant

Gi Supply

Camp Hill, PA10 decisions1992–20231 recall

FDA records 10 decisions for Gi Supply (Camp Hill, PA) from 1992 to 2023: 10 510(k) clearances. Most are in product codes PLL (Submucosal Injection Agent) and LYR (Helicobacter Pylori). Since 2016 its 510(k)s took a median of 338 days from receipt to decision, against 280 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Gi Supply, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Gi Supply’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 22023: 1
2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gi Supply by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gi Supply’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PLLSubmucosal Injection Agent2decisions
  • LYRHelicobacter Pylori2decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)2decisions
  • LROGeneral Surgery Tray1decision
  • MNKEndoscopic Bite Block1decision
  • FGEStents, Drains And Dilators For The Biliary Ducts1decision

Also: EOQ (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 338 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 280 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970186GI Supply Paracentesis PumpGi Supply · 19972cite it
  • K191923EverLift Submucosal Lifting AgentGi Supply · 20201cites it
  • K970187Runyon Large Volume Paracentesis KitGi Supply · 19971cites it
  • K931044Oxy-BlocGi Supply · 19931cites it
  • K915816Bite Block/Mouthpiece for EndoscopyGi Supply · 19921cites it

What has FDA decided for it lately?

  • K221042Renova RP Centesis PumpGi Supply, Inc. · 2023
  • K202376EverLift Submucosal Lifting AgentGi Supply, Inc. · 2020
  • K191923EverLift Submucosal Lifting AgentGi Supply · 2020
  • K031360GI Supply Biliary StentGi Supply · 2003
  • K012411HP-ONEGi Supply · 2001
  • K970187Runyon Large Volume Paracentesis KitGi Supply · 19971 recall
  • K970186GI Supply Paracentesis PumpGi Supply · 1997
  • K944903HP-FastGi Supply · 1995

All 8 as Gi Supply →All 2 as Gi Supply, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970187Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots…Jan 28, 2016Class II