RUNYON LARGE VOLUME PARACENTESIS KIT— 510(k) K970187

Name: FDA 510(k) clearance K970187
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K970187 for RUNYON LARGE VOLUME PARACENTESIS KIT, Substantially Equivalent on 1997-02-14. Applicant: Gi Supply. Device class: 2.

Clearance details

Applicant: Gi Supply
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-01-17
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willington, CT, US

Download summary PDF View on FDA.gov ↗

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K213481 — Medline General Surgery Tray2022-05-24
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K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL2004-11-30
K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE2003-03-31
K023276 — AMSINO TRACHEOSTOMY CARE TRAY2002-12-09

More clearances from Gi Supply

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K191923 — EverLift Submucosal Lifting Agent2020-06-20
K031360 — GI SUPPLY BILIARY STENT2003-09-24
K012411 — HP-ONE2001-09-25
K970186 — GI SUPPLY PARACENTESIS PUMP1997-02-14
K944903 — HP-FAST1995-04-20

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K970187

K-number listed on FDA's recall record

Z-1047-2016 — Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04Class II·Terminated·Gi Supply·20160128

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970187.

Data sourced from openFDA. This site is unofficial and independent of the FDA.