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FDA 510(k)

CAVERMAP SURGICAL AID

K-Number: K000507 · 2000-04-21

ApplicantUromed Corp.
Decision Date2000-04-21
Product CodeETN
Advisory CommitteeEN
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 2000-04-21 under 510(k) number K000507. The device is classified under product code ETN. It was reviewed by the EN 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 2000-04-21. The listed applicant is Uromed Corp.. The 510(k) number is K000507.

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

CAVERMAP SURGICAL AID received FDA 510(k) clearance on 2000-04-21, under 510(k) number K000507.

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 ETN.

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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 AIDK993436CAVERMAP SURGICAL AIDK982226UROMED BRACHYTHERAPHY IODINE-125 SOURCESK980717UROMED SLING KITK974600UROMED PATCH

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Related Devices (Code: ETN)

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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