Cleared Traditional

K932853 - PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932853 · Applied Osteo Systems, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
257d
Days
Class 2
Risk

K932853 is an FDA 510(k) clearance for the PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS. Classified as Curette, Biopsy, Bronchoscope (rigid) (product code JEL), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 257 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Osteo Systems, Inc. devices

Submission Details

510(k) Number K932853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1993
Decision Date February 22, 1994
Days to Decision 257 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 89d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEL Curette, Biopsy, Bronchoscope (rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.