Cleared Traditional

ASPIRATING HANDLE W/BACKFLUSHING CAPAB (K832560) - FDA 510(k) Clearance

K832560 · Precision Medical Instruments, Inc. · Gastroenterology & Urology device
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Jan 1984
Decision
156d
Days
-
Risk

K832560 is an FDA 510(k) clearance for the ASPIRATING HANDLE W/BACKFLUSHING CAPAB.

Submitted by Precision Medical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 156 days - an extended review cycle.

This device falls under the Gastroenterology & Urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Medical Instruments, Inc. devices

Submission Details

510(k) Number K832560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1983
Decision Date January 04, 1984
Days to Decision 156 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -