HI-TOPS ELECTRODES 14-8000— 510(k) K935947

Name: FDA 510(k) clearance K935947
Creator: U.S. Food and Drug Administration
Published: 1994-02-28

Substantially Equivalent

W. J. Medical Instruments, Inc.

FDA 510(k) clearance K935947 for HI-TOPS ELECTRODES 14-8000, Substantially Equivalent on 1994-02-28. Applicant: W. J. Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: W. J. Medical Instruments, Inc.
Product code: Product code KNF
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 1993-12-13
Decision date: 1994-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newbury Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNF

view all

K254303 — KARL STORZ SUPRALOOP2026-09-24
K250705 — Sonata Transcervical Fibroid Ablation System 2.22025-04-02
K240503 — Sonata Transcervical Fibroid Ablation System 2.22024-07-17
K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)2023-12-21
K222304 — Sonata Transcervical Fibroid Ablation System 2.22022-11-08

More clearances from W. J. Medical Instruments, Inc.

view all

K930508 — HIFLO FILTERED INSUFFLATION TUBING1993-06-25
K930511 — STEALTH SURGICAL IRRIGATOR ASPIRATOR1993-06-25

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