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FDA 510(k)

75K STAIGHT DRILL

K-Number: K943541 · 1995-05-18

ApplicantStryker Corp.
Decision Date1995-05-18
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

75K STAIGHT DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1995-05-18 under 510(k) number K943541. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 75K STAIGHT DRILL?

75K STAIGHT DRILL is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Stryker Corp.. The 510(k) number is K943541.

When did 75K STAIGHT DRILL receive FDA 510(k) clearance?

75K STAIGHT DRILL received FDA 510(k) clearance on 1995-05-18, under 510(k) number K943541.

Who is the listed applicant for 75K STAIGHT DRILL?

The FDA 510(k) record lists Stryker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 75K STAIGHT DRILL?

The FDA product code for 75K STAIGHT DRILL is HBE.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: HBE)

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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