Esophageal Bougies

FDA 510(k) K822258 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822258

Submission

Device name
Esophageal Bougies
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 29, 1982
Decision date
August 25, 1982
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
K844169VolumaticKCD · Traditional Glaxo, Inc.11/09/1984SE
K800623Jackson Esophageal Bougie, X-Ray OpaqueKCD · Traditional Pilling Co.04/24/1980SE

More from Pilling Co.

510(k)DeviceDecision
K822618Emergency Tracheostomy Instrument SetLJW · Traditional 01/28/1983SE
K822268Nagashima Ns-Iii ElectronystagmographGWN · Traditional 01/28/1983SE
K823083Electrosurgical UnitGEI · Traditional 12/07/1982SE
K823111Nystymograph AccessGNN · Traditional 11/22/1982SE
K822252ENT Treatment UnitsETF · Traditional 11/22/1982SE
K822272Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional 11/10/1982SE
K822017Tympanostomy Tubes & Various TypesETD · Traditional 10/27/1982SE
K822257Various Types of Light Source HandlesEOQ · Traditional 10/26/1982SE
K822259Laryngeal SpatulasEQH · Traditional 10/22/1982SE
K822004Face ShieldsKNT · Traditional 10/20/1982SE

Questions and answers

When was Esophageal Bougies cleared by the FDA?

Esophageal Bougies (K822258) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 27 days after the submission was received.

What is the product code of K822258?

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