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FDA 510(k)

CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE

K-Number: K884153 · 1988-12-28

ApplicantCandela Laser Corp.
Decision Date1988-12-28
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE 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 1988-12-28 under 510(k) number K884153. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE?

CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is Candela Laser Corp.. The 510(k) number is K884153.

When did CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE receive FDA 510(k) clearance?

CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE received FDA 510(k) clearance on 1988-12-28, under 510(k) number K884153.

Who is the listed applicant for CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE?

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 MINIFLEX DEFLECTABLE URETEROSCOPE?

The FDA product code for CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE is FGB.

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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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Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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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