Cleared Traditional

SUPERFLOW CANNULA FOR ARTHROS. SURGERY (K811115) - FDA 510(k) Clearance

K811115 · The Anspach Effort, Inc. · General & Plastic Surgery device
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Jul 1981
Decision
69d
Days
-
Risk

K811115 is an FDA 510(k) clearance for the SUPERFLOW CANNULA FOR ARTHROS. SURGERY.

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K811115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date July 01, 1981
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -