Pollack Chain Cysourethrogram Set

FDA 510(k) K810370 · Vance Products, Inc.

Substantially Equivalent

510(k) numberK810370

Submission

Device name
Pollack Chain Cysourethrogram Set
Applicant
Vance Products, Inc.
Mchenry, IL, US
Received
February 12, 1981
Decision date
March 20, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FGI – Catheter, Urethrographic, Male
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FGI

510(k)DeviceApplicantDecision
K023019Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000FGI · Traditional Vomed Volzer Medizintechnik GmbH & Co.12/10/2002SE
K013360Dfiner Urological CatheterFGI · Traditional Neoseed Technology,Llc02/20/2002SE

More from Neoseed Technology,Llc

510(k)DeviceDecision
K820313Vpi-Fair Urethral StentKOD · Traditional 03/01/1982SE
K812995Vance-Jacobellis Microhematuria CatheterKOD · Traditional 03/01/1982SE
K813278Vpi Ureteral Dilatation Ballon CatheterEZN · Traditional 12/18/1981SE
K812785Vance-Ambrose Resectoscope ForcepsGEN · Traditional 11/16/1981SE
K812057Vance CystoscopicFBK · Traditional 07/31/1981SE
K811833Vnace Fascial Dilator SetKOE · Traditional 07/10/1981SE
K811454Vance Prostatic Aspiration SetKNW · Traditional 06/09/1981SE
K810372Vance Deflectable Biopsy Brush SetKOD · Traditional 03/20/1981SE
K810371Vance Urethal Dilator SetKOE · Traditional 03/20/1981SE
K810368Vance Percutaneous Malecot NephrostomyKOB · Traditional 03/20/1981SE

Questions and answers

When was Pollack Chain Cysourethrogram Set cleared by the FDA?

Pollack Chain Cysourethrogram Set (K810370) received a 510(k) decision of Substantially Equivalent on March 20, 1981, 36 days after the submission was received.

What is the product code of K810370?

The FDA product code is FGI – Catheter, Urethrographic, Male, a Class II (moderate risk) device regulated under 21 CFR 876.5130.