Cleared Traditional

SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) (K903536) - FDA 510(k) Clearance

K903536 · Leonard Medical, Inc. · Cardiovascular device
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Sep 1990
Decision
30d
Days
-
Risk

K903536 is an FDA 510(k) clearance for the SMALL JOINT INSTRUMENTS (SCISSOR HANDLE).

Submitted by Leonard Medical, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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 Leonard Medical, Inc. devices

Submission Details

510(k) Number K903536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date September 06, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
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K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987