Suprapubic Trocar

FDA 510(k) K800607 · G.D. Searle and Co.

Substantially Equivalent

510(k) numberK800607

Submission

Device name
Suprapubic Trocar
Applicant
G.D. Searle and Co.
Mchenry, IL, US
Received
March 17, 1980
Decision date
April 8, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KOB – Catheter, Suprapubic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5090
Specialty
Gastroenterology, Urology
Implant
Yes

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K182709One-Step Suprapubic IntroducerKOB · Traditional Cook Incorporated12/26/2018SE
K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional Cook Incorporated10/30/2018SESK
K132890Suprapubic Catheter and Introducer SetKOB · Traditional Mediplus , Ltd.01/17/2014SE
K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional Swan Valley Medical, Incorporated10/26/2012SE
K014002All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional Fortune Medical Instrument Corp.03/04/2002SE
K012153Lowsley Suprapubic TractorKOB · Traditional Circon Video09/19/2001SE
K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional The Kendal Co.04/23/1997SE
K970021Rusch Suprapubic TrayKOB · Traditional Rusch, Inc.02/07/1997SE

More from Rusch, Inc.

510(k)DeviceDecision
K821159In-Line Oxygen Monitoring SystemDRY · Traditional 05/25/1982SE
K811068Bypass CoilKPY · Traditional 05/27/1981SE
K811071Venous Oxygen ProbeCCE · Traditional 05/05/1981SE
K803238Intravascular CatheterFOZ · Traditional 04/23/1981SE
K810630Silicone Elastomer Coated Latex FoleyKOD · Traditional 03/31/1981SE
K810131Administration SetFPD · Traditional 02/26/1981SE
K802485Searle Vascular LoopsKDC · Traditional 02/12/1981SE
K801805Metronidazole DiscsJWY · Traditional 02/10/1981SE
K810112SWR Disposable Prep RazorKDC · Traditional 02/04/1981SE
K802280White Knight Drape SealKKX · Traditional 10/10/1980SE

Questions and answers

When was Suprapubic Trocar cleared by the FDA?

Suprapubic Trocar (K800607) received a 510(k) decision of Substantially Equivalent on April 8, 1980, 22 days after the submission was received.

What is the product code of K800607?

The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.