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FDA 510(k)

R-MED MOTORIZED LAPAROSCOPIC HANDLE

K-Number: K945637 · 1994-12-07

ApplicantR-Med, Inc.
Decision Date1994-12-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

R-MED MOTORIZED LAPAROSCOPIC HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is R-Med, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K945637. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-MED MOTORIZED LAPAROSCOPIC HANDLE?

R-MED MOTORIZED LAPAROSCOPIC HANDLE is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is R-Med, Inc.. The 510(k) number is K945637.

When did R-MED MOTORIZED LAPAROSCOPIC HANDLE receive FDA 510(k) clearance?

R-MED MOTORIZED LAPAROSCOPIC HANDLE received FDA 510(k) clearance on 1994-12-07, under 510(k) number K945637.

Who is the listed applicant for R-MED MOTORIZED LAPAROSCOPIC HANDLE?

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

What is the FDA product code for R-MED MOTORIZED LAPAROSCOPIC HANDLE?

The FDA product code for R-MED MOTORIZED LAPAROSCOPIC HANDLE is GCJ.

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Other records listing R-Med, Inc. as applicant

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Related Devices (Code: GCJ)

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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