URETHRAL SOUND— 510(k) K800610

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K800610 for URETHRAL SOUND, Substantially Equivalent on 1980-04-08. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-17
Decision date: 1980-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOE

K191061 — Optilume Basic Urological Balloon Dilation Catheter2020-01-02
K032840 — ATRION MEDICAL QL INFLATION DEVICE2004-03-03
K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE1997-10-10
K962611 — BARD EAGLE INFLATION DEVICE1996-10-21
K961904 — AQ HYDROPHILIC DILATORS1996-10-18

More clearances from G.D. Searle and Co.

K821159 — IN-LINE OXYGEN MONITORING SYSTEM1982-05-25
K811068 — BYPASS COIL1981-05-27
K811071 — VENOUS OXYGEN PROBE1981-05-05
K803238 — INTRAVASCULAR CATHETER1981-04-23
K810630 — SILICONE ELASTOMER COATED LATEX FOLEY1981-03-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.