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FDA 510(k)

FOR USE IN EAR; NOSE & THROAT MICROSURGERY

K-Number: K852695 · 1985-08-30

ApplicantMinnesota Laser Corp.
Decision Date1985-08-30
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FOR USE IN EAR; NOSE & THROAT MICROSURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Laser Corp.. It received FDA 510(k) clearance on 1985-08-30 under 510(k) number K852695. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOR USE IN EAR; NOSE & THROAT MICROSURGERY?

FOR USE IN EAR; NOSE & THROAT MICROSURGERY is a medical device that received FDA 510(k) clearance on 1985-08-30. The listed applicant is Minnesota Laser Corp.. The 510(k) number is K852695.

When did FOR USE IN EAR; NOSE & THROAT MICROSURGERY receive FDA 510(k) clearance?

FOR USE IN EAR; NOSE & THROAT MICROSURGERY received FDA 510(k) clearance on 1985-08-30, under 510(k) number K852695.

Who is the listed applicant for FOR USE IN EAR; NOSE & THROAT MICROSURGERY?

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

What is the FDA product code for FOR USE IN EAR; NOSE & THROAT MICROSURGERY?

The FDA product code for FOR USE IN EAR; NOSE & THROAT MICROSURGERY is EWG.

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Other records listing Minnesota 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.

K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSK854468PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGICK854473PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGICK854471PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T

View all 12 devices →

Related Devices (Code: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, 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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