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FDA 510(k)

RIZA-RIBE NEEDLE (MODIFICATION)

K-Number: K954882 · 1995-11-16

ApplicantR-Med, Inc.
Decision Date1995-11-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIZA-RIBE NEEDLE (MODIFICATION) 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 1995-11-16 under 510(k) number K954882. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIZA-RIBE NEEDLE (MODIFICATION)?

RIZA-RIBE NEEDLE (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-11-16. The listed applicant is R-Med, Inc.. The 510(k) number is K954882.

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

RIZA-RIBE NEEDLE (MODIFICATION) received FDA 510(k) clearance on 1995-11-16, under 510(k) number K954882.

Who is the listed applicant for RIZA-RIBE NEEDLE (MODIFICATION)?

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 (MODIFICATION)?

The FDA product code for RIZA-RIBE NEEDLE (MODIFICATION) is HRX.

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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 ELEVATORK953441RIZA-RIBE NEEDLEK950108R-MED MINI-RETRACTORK942411R-MED DISPOSABLE PLUGK945637R-MED MOTORIZED LAPAROSCOPIC HANDLE

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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