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FDA 510(k)

MODIFICATION TO CAVERMAP SURGICAL AID

K-Number: K010098 · 2001-02-01

ApplicantUromed Corp.
Decision Date2001-02-01
Product CodeFGM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CAVERMAP SURGICAL AID is the device name listed in this FDA 510(k) record. The listed applicant is Uromed Corp.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K010098. 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 MODIFICATION TO CAVERMAP SURGICAL AID?

MODIFICATION TO CAVERMAP SURGICAL AID is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Uromed Corp.. The 510(k) number is K010098.

When did MODIFICATION TO CAVERMAP SURGICAL AID receive FDA 510(k) clearance?

MODIFICATION TO CAVERMAP SURGICAL AID received FDA 510(k) clearance on 2001-02-01, under 510(k) number K010098.

Who is the listed applicant for MODIFICATION TO CAVERMAP SURGICAL AID?

The FDA 510(k) record lists Uromed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO CAVERMAP SURGICAL AID?

The FDA product code for MODIFICATION TO CAVERMAP SURGICAL AID is FGM.

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Other records listing Uromed Corp. 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.

K010213MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP SURGICAL AIDK993436CAVERMAP SURGICAL AIDK982226UROMED BRACHYTHERAPHY IODINE-125 SOURCESK980717UROMED SLING KITK974600UROMED PATCH

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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 TechnologiesK993436CAVERMAP SURGICAL AIDUromed Corp.K944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, Inc.K944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT 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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