Cleared Traditional

K905433 - CODMAN DISPOSABLE SCALP CLIP APPLIER

K905433 is an FDA 510(k) clearance for CODMAN DISPOSABLE SCALP CLIP APPLIER, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code HBO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K905433 · Codman & Shurtleff, Inc. · Neurology device
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Feb 1991
Decision
79d
Days
Class 2
Risk

K905433 is an FDA 510(k) clearance for the CODMAN DISPOSABLE SCALP CLIP APPLIER. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4150 - 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K905433

510(k) Number K905433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date February 21, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBO Device Classification - Class 2, Special Controls

Product Code HBO Clip, Scalp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4150
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 Neurology devices follow this clearance model.

Regulatory Peers - HBO Clip, Scalp

Devices cleared under the same product code (HBO) and FDA review panel - the closest regulatory comparables to K905433.
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K883963 · New England Surgical Instrument Corp. · Oct 1988
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K881265 · Zimmer, Inc. · May 1988