Cleared Traditional

SILICONE PUTTY EAR PLUGS (K971517) - FDA 510(k) Clearance

K971517 · Bentec Medical, Inc. · Ear, Nose, Throat device
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Jun 1997
Decision
38d
Days
-
Risk

K971517 is an FDA 510(k) clearance for the SILICONE PUTTY EAR PLUGS. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Bentec Medical, Inc. (Sacramento, US). The FDA issued a Cleared decision on June 2, 1997 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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 Bentec Medical, Inc. devices

Submission Details

510(k) Number K971517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date June 02, 1997
Days to Decision 38 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 89d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -