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FDA 510(k)

CAUSSE SPONGE BOAT

K-Number: K841353 · 1984-07-06

ApplicantTreace Medical, Inc.
Decision Date1984-07-06
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CAUSSE SPONGE BOAT is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1984-07-06 under 510(k) number K841353. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAUSSE SPONGE BOAT?

CAUSSE SPONGE BOAT is a medical device that received FDA 510(k) clearance on 1984-07-06. The listed applicant is Treace Medical, Inc.. The 510(k) number is K841353.

When did CAUSSE SPONGE BOAT receive FDA 510(k) clearance?

CAUSSE SPONGE BOAT received FDA 510(k) clearance on 1984-07-06, under 510(k) number K841353.

Who is the listed applicant for CAUSSE SPONGE BOAT?

The FDA 510(k) record lists Treace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAUSSE SPONGE BOAT?

The FDA product code for CAUSSE SPONGE BOAT is ETB.

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Other records listing Treace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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