KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET— 510(k) K123941

Name: FDA 510(k) clearance K123941
Creator: U.S. Food and Drug Administration
Published: 2013-04-30

Substantially Equivalent

Spencer Fillmore

FDA 510(k) clearance K123941 for KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET, Substantially Equivalent on 2013-04-30. Applicant: Spencer Fillmore. Device class: 2.

Clearance details

Applicant: Spencer Fillmore
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2012-12-20
Decision date: 2013-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

view all

K262383 — LumenCare Azure2026-07-24
K252717 — MAASTRO Rectal Applicator Set2026-05-20
K251037 — Rectal Applicator2025-12-19
K252884 — Guided Aarhus Applicator Set2025-11-19
K250299 — CT/ MR Tandem and Ovoid Set2025-05-09

More clearances from Spencer Fillmore

view all

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