Cleared Traditional

SURE GRIP, HAND CONTROLS MODEL SG-1 (K910072) - FDA 510(k) Clearance

K910072 · Howell Ventures , Ltd. · Physical Medicine device
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Jan 1991
Decision
14d
Days
-
Risk

K910072 is an FDA 510(k) clearance for the SURE GRIP, HAND CONTROLS MODEL SG-1.

Submitted by Howell Ventures , Ltd. (Fredericton, N.B., CA). The FDA issued a Cleared decision on January 23, 1991 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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.

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Submission Details

510(k) Number K910072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date January 23, 1991
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPQ
Device Class -