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FDA 510(k)

CANDELA URETHRAL/BLADDER SOUND

K-Number: K950633 · 1995-03-06

ApplicantCandela Laser Corp.
Decision Date1995-03-06
Product CodeFBX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CANDELA URETHRAL/BLADDER SOUND is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K950633. The device is classified under product code FBX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA URETHRAL/BLADDER SOUND?

CANDELA URETHRAL/BLADDER SOUND is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Candela Laser Corp.. The 510(k) number is K950633.

When did CANDELA URETHRAL/BLADDER SOUND receive FDA 510(k) clearance?

CANDELA URETHRAL/BLADDER SOUND received FDA 510(k) clearance on 1995-03-06, under 510(k) number K950633.

Who is the listed applicant for CANDELA URETHRAL/BLADDER SOUND?

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

What is the FDA product code for CANDELA URETHRAL/BLADDER SOUND?

The FDA product code for CANDELA URETHRAL/BLADDER SOUND is FBX.

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Other records listing Candela Laser 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.

K951033ANDELA DYNAMIC COOLING DEVICEK955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK955011CANDELA HCS 2000 URETHERAL WARMER CATHETERK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEM

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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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