Cleared Traditional

K802463 - MICRO-SURGICAL POWER INSTRUMENT SYSTEM

K802463 is an FDA 510(k) clearance for MICRO-SURGICAL POWER INSTRUMENT SYSTEM, manufactured by Spire Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802463 · Spire Medical, Inc. · Ear, Nose, Throat device
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Oct 1980
Decision
22d
Days
Class 2
Risk

K802463 is an FDA 510(k) clearance for the MICRO-SURGICAL POWER INSTRUMENT SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Spire Medical, Inc. (Ventura, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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 Spire Medical, Inc. devices

FDA 510(k) Submission Details - K802463

510(k) Number K802463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1980
Decision Date October 31, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 59
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K802463.
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008 · Kelleher Corp. · Aug 1982
FISCH DRILL SYSTEM
K792159 · Jedmed Instrument Co. · Nov 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407 · Xomed, Inc. · Aug 1979
XOMED TRANSSPHENOIDAL HANDPIECE
K781418 · Xomed, Inc. · Aug 1978