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FDA 510(k)

SHARPE ENDOSPONGE ASPIIRATOR

K-Number: K921015 · 1993-05-21

ApplicantPaladin Medical, Inc.
Decision Date1993-05-21
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHARPE ENDOSPONGE ASPIIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Medical, Inc.. It received FDA 510(k) clearance on 1993-05-21 under 510(k) number K921015. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPE ENDOSPONGE ASPIIRATOR?

SHARPE ENDOSPONGE ASPIIRATOR is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K921015.

When did SHARPE ENDOSPONGE ASPIIRATOR receive FDA 510(k) clearance?

SHARPE ENDOSPONGE ASPIIRATOR received FDA 510(k) clearance on 1993-05-21, under 510(k) number K921015.

Who is the listed applicant for SHARPE ENDOSPONGE ASPIIRATOR?

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

What is the FDA product code for SHARPE ENDOSPONGE ASPIIRATOR?

The FDA product code for SHARPE ENDOSPONGE ASPIIRATOR is HET.

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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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