Jackson Esophageal Bougie, X-Ray Opaque

FDA 510(k) K800623 · Pilling Co.

Substantially Equivalent

510(k) numberK800623

Submission

Device name
Jackson Esophageal Bougie, X-Ray Opaque
Applicant
Pilling Co.
Mchenry, IL, US
Received
March 19, 1980
Decision date
April 24, 1980
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
K822258Esophageal BougiesKCD · Traditional Kelleher Corp.08/25/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K002582Pilling E-Frazier Bipolar Suction TubeGEI · Traditional 11/03/2000SE
K934427Pilling Laparoscopic InstrumentationGEI · Traditional 01/10/1994SE
K925370Triangular Jaw Microlaryngeal ForcepsELW · Traditional 03/18/1993SE
K925198Kaiser No Cannula Thoracoscopy/Laparoscopy InstrGCJ · Traditional 02/12/1993SE
K922971No-Scalpel Vascetomy InstrumentsKOA · Traditional 09/23/1992SE
K914015Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional 11/21/1991SE
K911099Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional 06/25/1991SE
K911100Mehigan-Pilling Phlebetome TMMGZ · Traditional 06/21/1991SE
K904507Pilling Brush ValvulotomeDWQ · Traditional 03/01/1991SE
K884946Jehle Coronary Perfusion CathetersKRA · Traditional 02/06/1989SE

Questions and answers

When was Jackson Esophageal Bougie, X-Ray Opaque cleared by the FDA?

Jackson Esophageal Bougie, X-Ray Opaque (K800623) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 36 days after the submission was received.

What is the product code of K800623?

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