Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Hand ligament surgical release instrument
Device Explorer · FDA GUDID · GMDN 58783

Hand ligament surgical release instrument

A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically

US‑registered devices142in commercial distribution
Companies12labelers on GUDID
Single‑use95%of device records
Sterile95%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Provision7754%
Medline Industries, Inc.2618%
A.M. Surgical, Inc.118%
Microaire Surgical Instruments Llc107%
Biomet Orthopedics, Llc64%
Suretek Medical54%
Spirecut Sa21%
Smith & Nephew, Inc.11%

Top labelers

CompanyDevicesShare
Provision7754%
Medline Industries, Inc.2618%
A.M. Surgical, Inc.118%
Microaire Surgical Instruments Llc107%
Biomet Orthopedics, Llc64%
Suretek Medical54%
Spirecut Sa21%
Smith & Nephew, Inc.11%
Rafael Medical Devices, Llc11%
Sonex Health, Inc.11%
Stryker Gmbh11%
Hand Biomechanics Lab Inc11%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ECTRAIndiana Tome®CARPAL TUNNEL RELEASECarpal Tunnel ReleaseSECURITY(TM) ENCLOSED CARPALCTR INDIANA TOME (SINGLE)VECTRSX-One MicroKnifeSTRATOS Endoscopic Release System (GEN 2) Case oSTRATOS (Gen2)ULTRA PROFILE2.7 mm Endoscopic Release SystemEndoscopic Scope-Mounting BladeClear Cannula4mm Endoscopic Release SystemUltra

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument73
EMFKnife, Surgical11
NBHAccessories, Arthroscopic11
GESBlade, Scalpel11
LXHOrthopedic manual surgical instrument9
GESBLADE, SCALPEL9

GMDN & GCC registration

  • GMDN code 58783 · non‑implantable
  • Single‑use 95% · sterile 95% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Millimeter) · 1Width (Millimeter) · 1Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many hand ligament surgical release instrument products are registered in the US?

142 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hand ligament surgical release instrument", from 12 companies. The largest labeler is Provision with 54% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), EMF (Knife, Surgical), NBH (Accessories, Arthroscopic), GES (Blade, Scalpel)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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