Cleared Traditional

K831426 - ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS (FDA 510(k) Clearance)

K831426 · New England Surgical Instrument Corp. · Orthopedic device
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Jun 1983
Decision
36d
Days
-
Risk

K831426 is an FDA 510(k) clearance for the ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS.

Submitted by New England Surgical Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. 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 New England Surgical Instrument Corp. devices

Submission Details

510(k) Number K831426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1983
Decision Date June 08, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -