Cleared Traditional

K002702 - NEUROTOLOGY DRAPE

K002702 is the FDA 510(k) clearance for NEUROTOLOGY DRAPE by Gyrus Ent LLC. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K002702 · Gyrus Ent LLC · General Hospital
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Oct 2000
Decision
57d
Days
Class 2
Risk

K002702 is an FDA 510(k) clearance for the NEUROTOLOGY DRAPE, MODEL TBD. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 Gyrus Ent LLC devices

Submission Details

510(k) Number K002702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date October 26, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 163
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K002702.
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · Advance Medical Designs, Inc. · Sep 2001
SURGICAL DRAPES
K011422 · Advance Medical Designs, Inc. · Jul 2001
PATIENT DRAPE, SURGICAL
K003670 · Advance Medical Designs, Inc. · Jan 2001
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp. · Sep 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000