Cleared Traditional

K841353 - CAUSSE SPONGE BOAT

K841353 is an FDA 510(k) clearance for CAUSSE SPONGE BOAT, manufactured by Treace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K841353 · Treace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
95d
Days
Class 2
Risk

K841353 is an FDA 510(k) clearance for the CAUSSE SPONGE BOAT. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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 Treace Medical, Inc. devices

FDA 510(k) Submission Details - K841353

510(k) Number K841353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date July 06, 1984
Days to Decision 95 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 90d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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.

Regulatory Peers - ETB Prosthesis, Partial Ossicular Replacement

All 54
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K841353.
INCUS/STAPES PROSTHESIS
K861369 · Richards Medical Co., Inc. · Jul 1986
MICROTEK STAINLESS STEEL PISTON
K860460 · Microtek Medical, Inc. · Jul 1986
INCUS PROSTHESIS
K844961 · Richards Medical Co., Inc. · Feb 1985
FISCH MODIFIED TEF-WIRE PISTON
K823429 · Treace Medical, Inc. · Dec 1982
CAUSSE TEF-PISTON
K823439 · Treace Medical, Inc. · Dec 1982
MCGEE MODIFIED STAINLESS STEEL PISTON
K823440 · Treace Medical, Inc. · Dec 1982