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Vacuum Cup (004SD)

by Swift Delivery Products

510(k) K963287

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963287 Date28 Oct 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HDB
Device Class
Class II
Regulation
21 CFR Part 884.4340
Advisory Committee
Obstetrics/Gynecology
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 Vacuum Cup (004sd) is a vacuum extractor cup, which is a type of device used in obstetrics and gynecology. It is classified as a class 2 device. The device is used as a fetal vacuum extractor.

The Vacuum Cup (004sd) is supplied by Swift Delivery Products and has been cleared by the FDA with a 510K number of K963287. It is intended for use in a medical setting and is regulated under the product code HDB. The device is associated with the medical specialty of obstetrics and gynecology.

Other devices from Swift Delivery Products

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 Vacuum Cup 004SD used for?

    The Vacuum Cup 004SD is used as a fetal vacuum extractor in obstetrics and gynecology, intended for use in a medical setting.

  • Is the Vacuum Cup 004SD a single-use or reusable device?

    The description does not specify whether the Vacuum Cup 004SD is single-use or reusable, but it is classified as a class 2 device.

  • What is the regulatory status of the Vacuum Cup 004SD?

    The Vacuum Cup 004SD has been cleared by the FDA with a 510K number of K963287, and is regulated under the product code HDB.

  • Who is the manufacturer of the Vacuum Cup 004SD?

    The Vacuum Cup 004SD is supplied by Swift Delivery Products.