Cleared Traditional

INSTRUMENTS NONSTERILE & STERILE (K802726) - FDA 510(k) Clearance

Class I Neurology device.

K802726 · Ascep, Inc. · Neurology device
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Nov 1980
Decision
23d
Days
Class 1
Risk

K802726 is an FDA 510(k) clearance for the INSTRUMENTS NONSTERILE & STERILE. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Ascep, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4535 - the FDA neurology 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 Ascep, Inc. devices

Submission Details

510(k) Number K802726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1980
Decision Date November 19, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HAO Instrument, Surgical, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HAO Instrument, Surgical, Non-powered

All 11
Devices cleared under the same product code (HAO) and FDA review panel - the closest regulatory comparables to K802726.
AUTO SUTURE SPINAL NERVE HOOK
K942969 · United States Surgical, A Division of Tyco Healthc · Jul 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · United States Surgical, A Division of Tyco Healthc · Jul 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · United States Surgical, A Division of Tyco Healthc · Jul 1994
SUBCUPASS TUNNELING TOOL
K780579 · Medtronic Vascular · May 1978
PERCUPASS TUNNELING TOOL MODEL 3452
K772013 · Medtronic Vascular · Oct 1977