VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM— 510(k) K002402

Name: FDA 510(k) clearance K002402
Creator: U.S. Food and Drug Administration
Published: 2000-08-31

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K002402 for VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM, Substantially Equivalent on 2000-08-31. Applicant: Mitek Products. Device class: 2.

Clearance details

Applicant: Mitek Products
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2000-08-07
Decision date: 2000-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Mitek Products

view all

K013572 — MITEK BIOCRYL INTERFERENCE SCREWS2002-03-14
K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT2002-02-06
K002639 — BIOKNOTLESS ANCHOR2001-05-11
K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM2001-05-09
K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM2001-02-15

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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