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Renton Suction Device U.S. Patent 4,767,404

by R&S Surgical, LLC

510(k) K962920

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 NumberK962920 Date21 Oct 1996ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
GCX
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Renton Suction Device U.S. Patent 4,767,404 is a surgical suction device featuring a perforated sleeve with suction ports arranged on the tip. This design allows unblocked ports to act as a vacuum modulator when other ports become obstructed by surgical debris, facilitating blockage removal and reducing the risk of complete blockage and tissue damage.

The device is supplied as a reusable surgical instrument and was cleared through the FDA 510(k) process under K962920 with product code GCX. It is intended for use in general hospital settings and is not described as sterile, single-use, or MRI-safe in the provided data. No specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance are specified in the device data.

Questions

AI-generated answers, 24 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 is the Renton Suction Device U.S. Patent 4,767,404 used for?

    The Renton Suction Device U.S. Patent 4,767,404 is a surgical suction device intended for use in general hospital settings. Its perforated sleeve with suction ports on the tip allows unblocked ports to act as a vacuum modulator when other ports become obstructed by surgical debris, facilitating blockage removal and reducing the risk of complete blockage and tissue damage during procedures.

  • Is the Renton Suction Device U.S. Patent 4,767,404 sterile or single-use?

    The device is supplied as a reusable surgical instrument and is not described as sterile or single-use in the provided data. It is intended for repeated use after appropriate cleaning and sterilization by the healthcare facility, consistent with its classification as a reusable instrument.

  • How was the Renton Suction Device U.S. Patent 4,767,404 cleared for market?

    The Renton Suction Device U.S. Patent 4,767,404 was cleared through the FDA 510(k) process under submission K962920 with product code GCX. The clearance decision was based on a determination of substantial equivalence to a legally marketed predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.