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FDA 510(k)

FLOWGUN ELECTROCAUTERY PROBE HANDLE

K-Number: K935970 · 1994-05-16

ApplicantO.R. Concepts, Inc.
Decision Date1994-05-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLOWGUN ELECTROCAUTERY PROBE HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Concepts, Inc.. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K935970. 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 FLOWGUN ELECTROCAUTERY PROBE HANDLE?

FLOWGUN ELECTROCAUTERY PROBE HANDLE is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is O.R. Concepts, Inc.. The 510(k) number is K935970.

When did FLOWGUN ELECTROCAUTERY PROBE HANDLE receive FDA 510(k) clearance?

FLOWGUN ELECTROCAUTERY PROBE HANDLE received FDA 510(k) clearance on 1994-05-16, under 510(k) number K935970.

Who is the listed applicant for FLOWGUN ELECTROCAUTERY PROBE HANDLE?

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

What is the FDA product code for FLOWGUN ELECTROCAUTERY PROBE HANDLE?

The FDA product code for FLOWGUN ELECTROCAUTERY PROBE HANDLE is GEI.

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Other records listing O.R. Concepts, Inc. as applicant

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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