Cleared Traditional

K971377 - GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K971377 · Wilson Greatbatch Technologies, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
381d
Days
Class 1
Risk

K971377 is an FDA 510(k) clearance for the GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE. 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 April 30, 1998 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K971377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date April 30, 1998
Days to Decision 381 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
242d slower than avg
Panel avg: 139d · This submission: 381d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.