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FDA 510(k)

ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG

K-Number: K944384 · 1995-02-15

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1995-02-15
Product CodeFGM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1995-02-15 under 510(k) number K944384. The device is classified under product code FGM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG?

ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG is a medical device that received FDA 510(k) clearance on 1995-02-15. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944384.

When did ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG receive FDA 510(k) clearance?

ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG received FDA 510(k) clearance on 1995-02-15, under 510(k) number K944384.

Who is the listed applicant for ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG?

The FDA 510(k) record lists Regulatory & Marketing Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG?

The FDA product code for ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG is FGM.

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Other records listing Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

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Related Devices (Code: FGM)

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.

K041732CAVERMAP SURGICAL AIDBlue Torch Medical TechnologiesK031527MODIFICATION TO CAVERMAP SURGICAL AIDBlue Torch Medical TechnologiesK010098MODIFICATION TO CAVERMAP SURGICAL AIDUromed Corp.K993436CAVERMAP SURGICAL AIDUromed Corp.K944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.K944378ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.

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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