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STD Irrigation Pump (K930427)

by Std Mfg., Inc.

510(k) K930427

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930427 Date1 Jun 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Std Irrigation Pump
510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The STD Irrigation Pump is a laparoscope irrigation device designed for controlled fluid delivery during surgical procedures. It facilitates irrigation of body cavities, ensuring proper visualization and maintenance of sterile conditions in minimally invasive and general/plastic surgery applications.

This device is intended for single-use in clinical settings and has received FDA 510(k) clearance under classification GCJ, with a decision of Substantially Equivalent (SESE). Supplied as a sterile, disposable unit, it adheres to regulatory standards for Class II medical devices and is approved for use in gastroenterology and urology procedures.

Other devices from Std Mfg., Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the STD Irrigation Pump specifically designed for, and how does it help during these procedures?

    The STD Irrigation Pump is designed for controlled fluid delivery during minimally invasive and general/plastic surgery procedures, particularly in gastroenterology and urology applications. It facilitates irrigation of body cavities, ensuring clear visualization of the surgical field and maintaining sterile conditions—critical for precision and safety during these procedures.

  • Is the STD Irrigation Pump intended for reuse, or is it meant to be used only once? How does this affect its use in clinical settings?

    The STD Irrigation Pump is explicitly designed for single-use in clinical settings. This design choice ensures sterility and reduces the risk of cross-contamination, aligning with best practices for surgical devices where reuse could compromise patient safety.

  • How is the STD Irrigation Pump supplied, and what does the sterile packaging ensure for the user?

    The device is supplied as a sterile, disposable unit, meaning it comes pre-packaged and ready for immediate use without additional sterilization. This ensures the user receives a clean, uncontaminated device, minimizing the risk of infection during surgery.

  • What regulatory pathway was followed for FDA clearance, and what does this mean for its classification and use?

    The STD Irrigation Pump received FDA 510(k) clearance under classification GCJ with a decision of *Substantially Equivalent (SESE)*. This means it was deemed comparable to a legally marketed predicate device, classifying it as a Class II medical device under FDA regulations, ensuring it meets established safety and performance standards for irrigation pumps in surgical settings.