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FDA 510(k)

ROTARY* POWERED SCALPEL

K-Number: K863731 · 1986-10-17

ApplicantSelf Sharpening Surgical Steel, Inc.
Decision Date1986-10-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROTARY* POWERED SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Self Sharpening Surgical Steel, Inc.. It received FDA 510(k) clearance on 1986-10-17 under 510(k) number K863731. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTARY* POWERED SCALPEL?

ROTARY* POWERED SCALPEL is a medical device that received FDA 510(k) clearance on 1986-10-17. The listed applicant is Self Sharpening Surgical Steel, Inc.. The 510(k) number is K863731.

When did ROTARY* POWERED SCALPEL receive FDA 510(k) clearance?

ROTARY* POWERED SCALPEL received FDA 510(k) clearance on 1986-10-17, under 510(k) number K863731.

Who is the listed applicant for ROTARY* POWERED SCALPEL?

The FDA 510(k) record lists Self Sharpening Surgical Steel, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTARY* POWERED SCALPEL?

The FDA product code for ROTARY* POWERED SCALPEL is GEI.

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Related Devices (Code: GEI)

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Official Source

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

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