FDA.reportPublic FDA data

Carpal tunnel release instrument

Definition
A sterile, hand-held, manual, surgical instrument designed for percutaneous or mini-open transection of the transverse carpal ligament for median nerve decompression. It typically consists of a tubular fenestrated probe that contains a wire with a toothed cutting segment, attached to a handle with a lever to extend and retract the wire. The probe is inserted through the carpal tunnel and the wire extended to expose the cutting section through the probe window, and distally through the skin so that it can be gripped to enable a manual sawing motion to transect the ligament. The probe may include a conductor for connecting to an external nerve-locating system. This is a single-use device.
GUDID devices
132
Last updated
2023-07-12 07:11:35

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B504CT9900990AM SurgicalProvision9900-992023-07-04
B504CT4500990AM SurgicalProvision4500-992023-06-21
B504OM3712100Aspen SurgicalProvision3712102023-05-18
B504OMAR2285100ArthrexProvisionAR-2285-102022-01-05
20888277375526MedlineMEDLINE INDUSTRIES, INC.81010R2022-07-15
20888277378138MedlineMEDLINE INDUSTRIES, INC.4058AR2022-05-13
20888277380568MedlineMEDLINE INDUSTRIES, INC.010600R2022-05-13
20888277382258MedlineMEDLINE INDUSTRIES, INC.3800010R2022-05-13
20888277386652MedlineMEDLINE INDUSTRIES, INC.3800006R2022-05-13
20888277370620MedlineMEDLINE INDUSTRIES, INC.3310BR2022-05-12
20888277370637MedlineMEDLINE INDUSTRIES, INC.450099R2022-05-12
20888277372600MedlineMEDLINE INDUSTRIES, INC.200060R2022-05-12
20888277372624MedlineMEDLINE INDUSTRIES, INC.2053R2022-05-12
20888277372631MedlineMEDLINE INDUSTRIES, INC.2055R2022-05-12
20888277372648MedlineMEDLINE INDUSTRIES, INC.2055AR2022-05-12
20888277372655MedlineMEDLINE INDUSTRIES, INC.2056R2022-05-12
20888277374130MedlineMEDLINE INDUSTRIES, INC.4447R2022-05-12
20888277374147MedlineMEDLINE INDUSTRIES, INC.4448R2022-05-12
20888277374154MedlineMEDLINE INDUSTRIES, INC.4449R2022-05-12
20888277383347MedlineMEDLINE INDUSTRIES, INC.2054R2022-05-12
20888277383798MedlineMEDLINE INDUSTRIES, INC.3056R2022-05-12
20888277384719MedlineMEDLINE INDUSTRIES, INC.3054R2022-05-12
B504CTCTR4550Hand Biomechanics LabProvisionCTR-4552022-04-13
10888277372610MedlineMEDLINE INDUSTRIES, INC.200068RH2022-04-08
10888277374102MedlineMEDLINE INDUSTRIES, INC.4116ARH2022-04-08
B504OM3757000BeaverProvision3757002022-03-28
B504OMAR1821S0ArthrexProvisionAR-1821S2022-02-08
B504OMAR19040ArthrexProvisionAR-19042022-02-08
B504CT8202010MicroAireProvision82020-12022-01-03
B504CT8303010MicroAireProvision83030-12022-01-03
00861994000281Disposable Blade AssemblyHand Biomechanics Lab IncCTR-4552021-12-06
B504OM005901020000ZimmerProvision00-5901-020-002021-10-05
B504OM030190260SynthesProvision03.019.0262021-10-05
B504OM31535000ExactechProvision315-35-002021-09-21
00887868471834Indiana Tome®Biomet Orthopedics, LLC2000602021-08-21
B504OM235130280StrykerProvision2351-30282021-08-05
B504OM2320240DePuy MitekProvision2320242021-05-21
B504OM144010800StrykerProvision1440-10802021-05-13
B504OM72072210Smith and NephewProvision72072212021-05-07
B504OM2321080DePuy MitekProvision2321082021-04-16
B504OM2321090DePuy MitekProvision2321092021-04-16
B504OM2321100DePuy MitekProvision2321102021-04-16
B504OM2321110DePuy MitekProvision2321112021-04-16
B504OM2321120DePuy MitekProvision2321122021-04-16
B504OM0101610Smith and NephewProvision0101612021-02-03
B504CT10030150MPRProvision10030-152021-01-27
00857915007644ULTRA HIGH PROFILEA.M. SURGICAL, INC.24502021-01-11
00860002094700SX-One MicroKnifeSONEX HEALTH, INC.600112-0012020-09-14
70880304279031Carpal Tunnel ReleaseBiomet Orthopedics, LLC2000702020-06-30
00880304000223CTR INDIANA TOME (SINGLE)Biomet Orthopedics, LLC2000602020-05-08
00880304279018Carpal Tunnel ReleaseBiomet Orthopedics, LLC2000682020-05-08
00810041633286StrykerProvision20542019-12-13
00810041633293Sustainable TechnologiesProvisionST20552019-12-13
00810041633309StrykerProvision2055-A2019-12-13
00810041631442SegWayProvision200-10032019-12-13
00810041631459SegWayProvision200-10062019-12-13
00810041631510Smith and NephewProvision0106002019-12-13
00810041631657Smith and NephewProvision44472019-12-13
00810041631664Sustainable TechnologiesProvisionST44482019-12-13
00810041631671Sustainable TechnologiesProvisionST44492019-12-13
00810041069108Sustainable TechnologiesProvisionST08-00032019-12-13
00810041069214Sustainable TechnologiesProvisionST81010-12019-12-13
00810041066763Sustainable TechnologiesProvisionST99712019-12-13
00810041063403Sustainable TechnologiesProvisionST2000602019-12-13
00810041063410BiometProvision2000682019-12-13
00887868164262CARPAL TUNNEL RELEASEBiomet Orthopedics, LLC2000672017-07-28
00810041061669AM Surgical Provision33102019-12-13
00810041061676AM Surgical Provision99002019-12-13
03596010128522ECTRASmith & Nephew, Inc.42832015-08-23
00857915007491Clear CannulaA.M. SURGICAL, INC.9600-222020-01-15
108579150074744mm Endoscopic Release SystemA.M. SURGICAL, INC.9900-992020-01-15
10857915007504Endoscopic Scope-Mounting BladeA.M. SURGICAL, INC.99002020-01-15
108579150075112.7 mm Endoscopic Release SystemA.M. SURGICAL, INC.4500-992020-01-15
08100410601674AM Surgical Provision3310-B2019-12-13
08100410601681AM Surgical Provision9900-B2019-12-13
08100410603418BiometProvision2000602019-12-13
08100410603425BiometProvision2000682019-12-13
08100410606778Conmed/LinvatecProvision99712019-12-13
08100410609113Integra Provision08-00032019-12-13
08100410609229MicroAireProvision81010-12019-12-13