Cleared Traditional

K945761 - LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP

K945761 is an FDA 510(k) clearance for LOW TEMPERATURE CAUTERY FINE TIP, manufactured by Aaron Medical Industries. The device is a Class 2 Ophthalmic device with product code HQP cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K945761 · Aaron Medical Industries · Ophthalmic device
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Apr 1995
Decision
152d
Days
Class 2
Risk

K945761 is an FDA 510(k) clearance for the LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aaron Medical Industries devices

FDA 510(k) Submission Details - K945761

510(k) Number K945761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date April 10, 1995
Days to Decision 152 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 110d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQP Device Classification - Class 2, Special Controls

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

All 14
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K945761.
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
K062659 · Kirwan Surgical Products, Inc. · Mar 2007
CAUTERY GRASPER/DISSECTOR
K994019 · Starion Instruments · Jan 2000
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · Starion Instruments · Jun 1999
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