Cleared Traditional

K971377 - GREATBATCH SCIENTIFIC MR COMPATIBLE LAR...

K971377 is an FDA 510(k) clearance for GREATBATCH SCIENTIFIC MR COMPATIBLE LAR..., 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 381-day FDA review.

K971377 · Wilson Greatbatch Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K971377

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
241d slower than avg
Panel avg: 140d · This submission: 381d
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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