Volumatic

FDA 510(k) K844169 · Glaxo, Inc.

Substantially Equivalent

510(k) numberK844169

Submission

Device name
Volumatic
Applicant
Glaxo, Inc.
Research Triangle, NC, US
Received
October 25, 1984
Decision date
November 9, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KCD – Bougie, Esophageal, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KCD

510(k)DeviceApplicantDecision
K822258Esophageal BougiesKCD · Traditional Kelleher Corp.08/25/1982SE
K800623Jackson Esophageal Bougie, X-Ray OpaqueKCD · Traditional Pilling Co.04/24/1980SE

More from Pilling Co.

510(k)DeviceDecision
K954041G.R.E.E.N. Disposal Container (Note: G.R.E.E.N. Is an Acronym for Glaxo Retrieval Effort…FMI · Traditional 10/16/1995SE
K922187Compact SpacerCAF · Traditional 11/20/1992SE
K901803Syringe Needle IntroducerKZH · Traditional 11/20/1990SE

Questions and answers

When was Volumatic cleared by the FDA?

Volumatic (K844169) received a 510(k) decision of Substantially Equivalent on November 9, 1984, 15 days after the submission was received.

What is the product code of K844169?

The FDA product code is KCD – Bougie, Esophageal, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.