Cleared Traditional

K970619 - GREATBATCH SCIENTIFIC MRI COMPATIBLE FI...

K970619 is an FDA 510(k) clearance for GREATBATCH SCIENTIFIC MRI COMPATIBLE FI..., manufactured by Wilson Greatbatch Technologies, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K970619 · Wilson Greatbatch Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
274d
Days
Class 1
Risk

K970619 is an FDA 510(k) clearance for the GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Wilson Greatbatch Technologies, Inc. (Clarence, US). The FDA issued a Cleared decision on November 19, 1997 after a review of 274 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wilson Greatbatch Technologies, Inc. devices

FDA 510(k) Submission Details - K970619

510(k) Number K970619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date November 19, 1997
Days to Decision 274 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 140d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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 - CCW Laryngoscope, Rigid

All 9
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