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FDA 510(k)

RIZA-RIBE NEEDLE

K-Number: K935031 · 1994-04-25

ApplicantR-Med, Inc.
Decision Date1994-04-25
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RIZA-RIBE NEEDLE 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 1994-04-25 under 510(k) number K935031. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIZA-RIBE NEEDLE?

RIZA-RIBE NEEDLE is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is R-Med, Inc.. The 510(k) number is K935031.

When did RIZA-RIBE NEEDLE receive FDA 510(k) clearance?

RIZA-RIBE NEEDLE received FDA 510(k) clearance on 1994-04-25, under 510(k) number K935031.

Who is the listed applicant for RIZA-RIBE NEEDLE?

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 RIZA-RIBE NEEDLE?

The FDA product code for RIZA-RIBE NEEDLE is HET.

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Other records listing R-Med, 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.

K001236RIZA BAND STRETCHER (RBS)-60000K953360R-MED ABDOMINAL WALL ELEVATORK954882RIZA-RIBE NEEDLE (MODIFICATION)K953441RIZA-RIBE NEEDLEK950108R-MED MINI-RETRACTORK942411R-MED DISPOSABLE PLUG

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Related Devices (Code: HET)

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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