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FDA 510(k)

CANDELA MINI-UB ENDOSCOPE

K-Number: K910732 · 1991-04-12

ApplicantCandela Laser Corp.
Decision Date1991-04-12
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CANDELA MINI-UB ENDOSCOPE 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 1991-04-12 under 510(k) number K910732. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA MINI-UB ENDOSCOPE?

CANDELA MINI-UB ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Candela Laser Corp.. The 510(k) number is K910732.

When did CANDELA MINI-UB ENDOSCOPE receive FDA 510(k) clearance?

CANDELA MINI-UB ENDOSCOPE received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910732.

Who is the listed applicant for CANDELA MINI-UB ENDOSCOPE?

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 MINI-UB ENDOSCOPE?

The FDA product code for CANDELA MINI-UB ENDOSCOPE is ODF.

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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: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200Lumenis, Inc.K090170SPYSCOPE ACCESS AND DELIVERY CATHETERBoston Scientific CorpK052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK9633545 STAR MEDICAL ENDOSCOPEFive Star Medical, 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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