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FDA 510(k)

FLOWGUN ELECTROCAUTERY PROBES

K-Number: K935971 · 1994-05-16

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

Device Summary

FLOWGUN ELECTROCAUTERY PROBES 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 K935971. 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 PROBES?

FLOWGUN ELECTROCAUTERY PROBES 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 K935971.

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

FLOWGUN ELECTROCAUTERY PROBES received FDA 510(k) clearance on 1994-05-16, under 510(k) number K935971.

Who is the listed applicant for FLOWGUN ELECTROCAUTERY PROBES?

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 PROBES?

The FDA product code for FLOWGUN ELECTROCAUTERY PROBES 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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