Cleared Traditional

K121441 - CAUTERY

Also marketed or referenced as:
LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

K121441 is the FDA 510(k) clearance for CAUTERY by Bovie Medical Corporation. It is a Class 2 Ophthalmic device (product code HQP) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K121441 · Bovie Medical Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
66d
Days
Class 2
Risk

K121441 is an FDA 510(k) clearance for the CAUTERY. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Bovie Medical Corporation (Clearwater, US). The FDA issued a Cleared decision on July 20, 2012 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bovie Medical Corporation devices

Submission Details

510(k) Number K121441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2012
Decision Date July 20, 2012
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 110d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQP Unit, Cautery, Thermal, Battery-powered

Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K121441.
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
K945761 · Aaron Medical Industries · Apr 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE
K945762 · Aaron Medical Industries · Feb 1995
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
K945763 · Aaron Medical Industries · Feb 1995
OPHTHALMIC CAUTERY
K945493 · Aaron Medical Industries · Jan 1995
XOMED THERMAL MYRINGOTOMY SYSTEM
K820157 · Xomed, Inc. · Mar 1982
HOT TEMP CAUTERY
K771189 · Edward Weck, Inc. · Jul 1977