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FDA 510(k)

CAVERMAP SURGICAL AID

K-Number: K993436 · 2000-02-11

ApplicantUromed Corp.
Decision Date2000-02-11
Product CodeFGM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 2000-02-11 under 510(k) number K993436. 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 CAVERMAP SURGICAL AID?

CAVERMAP SURGICAL AID is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Uromed Corp.. The 510(k) number is K993436.

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

CAVERMAP SURGICAL AID received FDA 510(k) clearance on 2000-02-11, under 510(k) number K993436.

Who is the listed applicant for 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 CAVERMAP SURGICAL AID?

The FDA product code for CAVERMAP SURGICAL AID is FGM.

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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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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 AIDK010098MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP 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 TechnologiesK010098MODIFICATION TO CAVERMAP 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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