ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS— 510(k) K972856

Name: FDA 510(k) clearance K972856
Creator: U.S. Food and Drug Administration
Published: 1998-02-11

Substantially Equivalent

Rocket Medical Plc

FDA 510(k) clearance K972856 for ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS, Substantially Equivalent on 1998-02-11. Applicant: Rocket Medical Plc. Device class: 2.

Clearance details

Applicant: Rocket Medical Plc
Product code: Code KNF
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 1997-08-01
Decision date: 1998-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNF

view all

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
K211535 — Sonata Transcervical Fibroid Ablation System 2.22021-06-17

More clearances from Rocket Medical Plc

view all

K210509 — Rocket Platinum Cured Cathter2021-09-09
K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit2017-08-17
K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit2016-11-14
K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set2016-03-29
K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B2013-02-01

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