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FDA 510(k)

ENDO-BEND(TM) SHAVER

K-Number: K950054 · 1995-06-29

ApplicantPaladin Medical, Inc.
Decision Date1995-06-29
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDO-BEND(TM) SHAVER 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 1995-06-29 under 510(k) number K950054. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-BEND(TM) SHAVER?

ENDO-BEND(TM) SHAVER is a medical device that received FDA 510(k) clearance on 1995-06-29. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K950054.

When did ENDO-BEND(TM) SHAVER receive FDA 510(k) clearance?

ENDO-BEND(TM) SHAVER received FDA 510(k) clearance on 1995-06-29, under 510(k) number K950054.

Who is the listed applicant for ENDO-BEND(TM) SHAVER?

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 ENDO-BEND(TM) SHAVER?

The FDA product code for ENDO-BEND(TM) SHAVER is HRX.

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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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