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FDA 510(k)

RUNYON LARGE VOLUME PARACENTESIS KIT

K-Number: K970187 · 1997-02-14

ApplicantGi Supply
Decision Date1997-02-14
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RUNYON LARGE VOLUME PARACENTESIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K970187. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUNYON LARGE VOLUME PARACENTESIS KIT?

RUNYON LARGE VOLUME PARACENTESIS KIT is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Gi Supply. The 510(k) number is K970187.

When did RUNYON LARGE VOLUME PARACENTESIS KIT receive FDA 510(k) clearance?

RUNYON LARGE VOLUME PARACENTESIS KIT received FDA 510(k) clearance on 1997-02-14, under 510(k) number K970187.

Who is the listed applicant for RUNYON LARGE VOLUME PARACENTESIS KIT?

The FDA 510(k) record lists Gi Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUNYON LARGE VOLUME PARACENTESIS KIT?

The FDA product code for RUNYON LARGE VOLUME PARACENTESIS KIT is LRO.

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Other records listing Gi Supply as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191923EverLift Submucosal Lifting AgentK031360GI SUPPLY BILIARY STENTK012411HP-ONEK970186GI SUPPLY PARACENTESIS PUMPK944903HP-FASTK931044OXY-BLOC

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Related Devices (Code: LRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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