Cleared Traditional

K972060 - NASAL SEPTAL BUTTON

K972060 · Boston Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
31d
Days
-
Risk

K972060 is an FDA 510(k) clearance for the NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 31 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.

FDA 510(k) Submission Details - K972060

510(k) Number K972060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date July 03, 1997
Days to Decision 31 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 90d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

LFB Device Classification - Class 0,

Product Code LFB Button, Nasal Septal
Device Class -

Regulatory Peers - LFB Button, Nasal Septal

All 7
Devices cleared under the same product code (LFB) and FDA review panel - the closest regulatory comparables to K972060.
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
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