Cleared Traditional

K994019 - CAUTERY GRASPER/DISSECTOR

K994019 is an FDA 510(k) clearance for CAUTERY GRASPER/DISSECTOR, manufactured by Starion Instruments. The device is a Class 2 Ophthalmic device with product code HQP cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K994019 · Starion Instruments · Ophthalmic device
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Jan 2000
Decision
55d
Days
Class 2
Risk

K994019 is an FDA 510(k) clearance for the CAUTERY GRASPER/DISSECTOR. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 55 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 Starion Instruments devices

FDA 510(k) Submission Details - K994019

510(k) Number K994019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date January 20, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 110d · This submission: 55d
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 13
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K994019.
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
K062659 · Kirwan Surgical Products, Inc. · Mar 2007
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · Starion Instruments · Jun 1999
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