Cleared Traditional

K002547 - STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

K002547 is an FDA 510(k) clearance for STARION INSTRUMENTS POWER POINT CAUTERY..., 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 64-day FDA review.

K002547 · Starion Instruments · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
64d
Days
Class 2
Risk

K002547 is an FDA 510(k) clearance for the STARION INSTRUMENTS POWER POINT 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 October 20, 2000 after a review of 64 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.

FDA 510(k) Submission Details - K002547

510(k) Number K002547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 20, 2000
Days to Decision 64 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
46d faster than avg
Panel avg: 110d · This submission: 64d
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 18
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K002547.
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
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K062659 · Kirwan Surgical Products, Inc. · Mar 2007
SURGICAL MEDICAL DEVICE CAUTERY
K023506 · Modern Medical Equipment Mfg., Ltd. · Jan 2004
CAUTERY GRASPER/DISSECTOR
K994019 · Starion Instruments · Jan 2000
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · Starion Instruments · Jun 1999
OXBORO-MEDICAL CAUTERY TIP CLEANER
K952784 · Oxboro Medical Intl., Inc. · Jul 1995
K002547 · STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
Download PDF FDA Summary Starion Instruments