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FDA 510(k)

MODIFICATION TO CAVERMAP SURGICAL AID

K-Number: K031527 · 2003-06-05

ApplicantBlue Torch Medical Technologies
Decision Date2003-06-05
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 Blue Torch Medical Technologies. It received FDA 510(k) clearance on 2003-06-05 under 510(k) number K031527. 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 2003-06-05. The listed applicant is Blue Torch Medical Technologies. The 510(k) number is K031527.

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

MODIFICATION TO CAVERMAP SURGICAL AID received FDA 510(k) clearance on 2003-06-05, under 510(k) number K031527.

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

The FDA 510(k) record lists Blue Torch Medical Technologies 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.

Related Clinical Trials

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 Blue Torch Medical Technologies 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.

K041732CAVERMAP SURGICAL AID

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 TechnologiesK010098MODIFICATION TO CAVERMAP SURGICAL AIDUromed Corp.K993436CAVERMAP 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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