Argyle Rapid Gastric Lavage Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K770248 ↗

FDA Product Code

KDH

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Lancer Glucose Rate Reagent Kit

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  FDA 510(k) K801071 Active Cleared 23 May 1980

• Blood Collection Tube, Lavender

  Class II

  FDA 510(k) K771052 Active Cleared 27 Jun 1977

• Catheter, Argyle Thoracic

  Class I

  FDA 510(k) K760351 Active Cleared 23 Aug 1976

• Sump Drain, W/Filter, Argyle Edlich

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  FDA 510(k) K770442 Active Cleared 30 Mar 1977

• Lancer L-Ina Human Reference Serum

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• Reagent Kit, Lancer Glucose

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  FDA 510(k) K790197 Active Cleared 12 Mar 1979

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• What is the Argyle Rapid Gastric Lavage Kit used for?

  The Argyle Rapid Gastric Lavage Kit is a Class II catheter system designed for gastric, colonic and related irrigation and aspiration procedures. It provides a closed-system conduit for the safe removal of stomach contents during lavage or decontamination procedures.

• How is the Argyle Rapid Gastric Lavage Kit supplied?

  The kit is supplied as a fully assembled, disposable set that includes a 140 cc (5 oz) graduated syringe and a clamp, forming a closed system to protect healthcare personnel from exposure during procedures.

• Is the Argyle Rapid Gastric Lavage Kit single-use or reusable?

  The Argyle Rapid Gastric Lavage Kit is intended for single-use only. It is a disposable system designed to be used once and then discarded to maintain sterility and prevent cross-contamination.

• What is the regulatory status of the Argyle Rapid Gastric Lavage Kit?

  The Argyle Rapid Gastric Lavage Kit is regulated under product code KDH and received FDA 510(k) clearance (K770248) on March 9, 1977, with a decision description of 'Substantially Equivalent' under review by the Gastroenterology, Urology advisory committee.