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FDA 510(k)

SHARPE ENDOSCALPEL

K-Number: K920548 · 1992-09-22

ApplicantPaladin Medical, Inc.
Decision Date1992-09-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHARPE ENDOSCALPEL 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 1992-09-22 under 510(k) number K920548. 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 ENDOSCALPEL?

SHARPE ENDOSCALPEL is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K920548.

When did SHARPE ENDOSCALPEL receive FDA 510(k) clearance?

SHARPE ENDOSCALPEL received FDA 510(k) clearance on 1992-09-22, under 510(k) number K920548.

Who is the listed applicant for SHARPE ENDOSCALPEL?

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 ENDOSCALPEL?

The FDA product code for SHARPE ENDOSCALPEL 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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