FDA.reportPublic FDA data

ENT shaver system

Definition
An assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.
GUDID devices
78
Last updated
2026-06-05 06:05:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00821925043145DIEGO ELITEGyrus ACMI, LLCMB4000SC2024-07-24
00821925043169DIEGO ELITEGyrus ACMI, LLCMM4000SC2024-07-24
00821925038134DIEGO ELITEGyrus ACMI, LLCBB4000SS2016-10-13
00821925038424DIEGO ELITEGyrus ACMI, LLCLB2927SS2018-09-13
00821925038431DIEGO ELITEGyrus ACMI, LLCMB4000SS2016-10-14
00821925038530DIEGO ELITEGyrus ACMI, LLCMM4000SS2016-10-14
00821925040519GYRUS ACMIGyrus ACMI, LLC703369002017-05-11
00821925040564DIEGO ELITEGyrus ACMI, LLCBB4040SS2016-10-04
00821925040571DIEGO ELITEGyrus ACMI, LLCBB4040XS2016-10-04
00821925040625DIEGO ELITEGyrus ACMI, LLCLB2922SS2018-09-13
00821925040632DIEGO ELITEGyrus ACMI, LLCLB4022SD2018-09-13
00821925040700Diego EliteGyrus ACMI, LLCNCGRIP2016-10-05
00821925042353DIEGO ELITEGyrus ACMI, LLCBEMTS101DC2016-10-05
00821925043084DIEGO ELITEGyrus ACMI, LLCBB4000SC2024-07-25
00821925043107DIEGO ELITEGyrus ACMI, LLCBB4040SC2024-07-24
00821925043183DIEGO ELITEGyrus ACMI, LLCMS4000SC2024-07-24
04048551273487n.a.Karl Storz GmbH & Co. KG41201FD2019-02-23
B504ES701380340Gyrus ACMIProvision701380342023-07-13
04048551071601UNIDRIVEKarl Storz GmbH & Co. KG20711620-12016-09-23
04048551159439n.a.Karl Storz GmbH & Co. KG40201RN2016-09-23
B504ES62902080250StrykerProvision6290-208-0252024-09-30
B504ES701380150Gyrus ACMIProvision701380152024-08-12
B504ES701380160Gyrus ACMIProvision701380162024-08-12
00821925043077DIEGO ELITEGyrus Acmi, Inc.BB4000SC2024-07-25
00821925043121DIEGO ELITEGyrus ACMI, LLCBB4040XC2024-07-25
00821925043091DIEGO ELITEGyrus Acmi, Inc.BB4040SC2024-07-24
00821925043138DIEGO ELITEGyrus Acmi, Inc.MB4000SC2024-07-24
00821925043152DIEGO ELITEGyrus Acmi, Inc.MM4000SC2024-07-24
00821925043176DIEGO ELITEGyrus Acmi, Inc.MS4000SC2024-07-24
B504ES1884015RTD0MedtronicProvision1884015RTD2024-05-22
B504ES1885078HSE0MedtronicProvision1885078HSE2024-05-22
B504ES701380040Gyrus ACMIProvision701380042024-05-13
B504ES701380180Gyrus ACMIProvision701380182024-05-13
B504ES1883070BLD0MedtronicProvision1883070BLD2024-03-28
B504ES1883264HS0MedtronicProvision1883264HS2024-03-28
B504ES18829160MedtronicProvision18829162024-02-14
B504ES41304KKB0Karl StorzProvision41304KKB2024-02-14
B504ES62901120400StrykerProvision6290-112-0402024-02-14
B504ES52900110000StrykerProvision5290-011-0002024-01-16
B504ES701380000Gyrus ACMIProvision701380002023-08-30
B504ES701381000Gyrus ACMIProvision701381002023-08-30
B504ESSSB1236010Entellus MedicalProvisionSSB-12360-12023-08-28
B504ES18820400MedtronicProvision18820402023-06-19
B504ES18829400MedtronicProvision18829402023-06-19
B504ES18840040MedtronicProvision18840042023-06-08
B504ES52906280000StrykerProvision5290-628-0002023-06-08
B504ES52906350000StrykerProvision5290-635-0002023-06-08
J00717003000011Set OSSEOUNO + S120Bien-Air Surgery SA17003002019-01-07
00857326005635Entellus MedicalSTRYKER CORPORATIONSS-1002020-09-24
00821925011434Gyrus ACMIGyrus ACMI, LLC703370042017-05-11
00821925011441DIEGOGyrus ACMI, LLC703380002017-05-11
00821925022829DiegoGyrus ACMI, LLC70921849D2017-05-11
00821925026070DiegoGyrus ACMI, LLC70338000R2017-05-11
00821925026148DiegoGyrus ACMI, LLC703380102016-10-12
00821925026155DIEGO ELITEGyrus ACMI, LLC703380112016-10-12
00821925026162DIEGO ELITEGyrus ACMI, LLC70338011R2016-10-06
00821925026179DiegoGyrus ACMI, LLC703380122016-10-06
00821925026186DiegoGyrus ACMI, LLC703380132016-10-12
00821925027749DIEGO ELITEGyrus ACMI, LLCMDHP100A2016-10-14
00821925027756DIEGO ELITEGyrus ACMI, LLCMDHP100S2016-10-05
00821925027770DIEGO ELITEGyrus ACMI, LLCMDCONS1002016-10-14
00821925027787DIEGO ELITEGyrus ACMI, LLCMDFS1002016-10-14
00821925027794DIEGO ELITEGyrus ACMI, LLCMDSM110V2017-05-11
00821925027800DIEGO ELITEGyrus ACMI, LLCMDSM220V2017-05-11
00821925028715GYRUS ACMIGyrus ACMI, LLC703255522017-05-11
00821925028722GYRUS ACMIGyrus ACMI, LLC703255532017-05-11
00821925028746DiegoGyrus ACMI, LLC703390002016-10-06
00821925026223DIEGO SUCTION-IRRIGATION TUBING SET, DISPOSABLE 12'(3.66 m) LENGTH NGyrus Acmi, Inc.703380032016-10-12
00821925026254DIEGO TRIGGER SWITCH STERILE, DISPOSABLEGyrus Acmi, Inc.703380082016-10-12
00821925026131DIEGO HANDPIECE CLEANING KIT NONSTERILE .475"(12.07mm) DIA and .437"Gyrus Acmi, Inc.703380092016-10-12
00821925026247DIEGO OTOLOGY TUBE SET FOR USE WITH VIPER HANDPIECES 40" (101.6 cm)LGyrus Acmi, Inc.703380072016-10-06
00821925027817DIEGO ELITE TUBESET, STANDARDGyrus Acmi, Inc.TS100S2016-10-18
00821925027824DIEGO ELITE TUBESET, DECLOGGyrus Acmi, Inc.TS101DC2016-10-18
00821925027268DIEGO IRRIGATION TUBE SET FOR USE WITH VIPER HANDPIECES 12'(3.66 m)Gyrus Acmi, Inc.703369002017-05-11
00821925027831TUBESET WITH FILTER FOR SUCTION MODULE DIEGO ELITEGyrus Acmi, Inc.TS102SF2016-10-06
00821925040694Nosecone Adapter Grip Diego EliteGyrus Acmi, Inc.NCGRIP2016-10-05
00821925042346BRACKET EM COMPATIBLE DIEGO ELITEGyrus Acmi, Inc.BEMTS101DC2016-10-05
00821925042360DIEGOGyrus ACMI, LLC70339000R2016-10-06