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Device Explorer · FDA GUDID · GMDN 13509

Gallstone scoop

A hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a

US‑registered devices124in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Sklar Corporation2520%
Rz-Medizintechnik Gmbh1815%
Avalign Technologies, Inc.1613%
Integra Lifesciences Production Corporation108%
Schobell Industrial Ltda97%
Sontec Instruments, Inc.76%
Novo Surgical, Inc.76%
Gimmi Gmbh65%

Top labelers

CompanyDevicesShare
Sklar Corporation2520%
Rz-Medizintechnik Gmbh1815%
Avalign Technologies, Inc.1613%
Integra Lifesciences Production Corporation108%
Schobell Industrial Ltda97%
Sontec Instruments, Inc.76%
Novo Surgical, Inc.76%
Gimmi Gmbh65%
Aspen Surgical Products, Inc.65%
Teleflex Incorporated65%
Steris Corporation43%
Anmuth Medical International, Llc43%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RZ Medizintechnik GmbHGimmiSymmetry DesjardinsSymmetry FergusonGEN2DAVIS GALL STONE SCOOPDAVIS GALLSTONE SCOOPMAYO GALLSTONE SCOOPFERGUSON GALLSTONE SCOOPMillenniumAvalignAmbler SurgicalAmerican MedicalsPILLINGV. MuellerSklar

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

FDA product codes

CodeNameDevices
FHLSCOOP61
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE23
FHLScoop21
FGMProbe And Director, Gastro-Urology7
MDMInstrument, Manual, Surgical, General Use4
HTDFORCEPS4

GMDN & GCC registration

  • GMDN code 13509 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 68% · 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

Length (Inch) · 14Catheter Gauge (French) · 4Circumference (Millimeter) · 2Width (Millimeter) · 1Length (Millimeter) · 1

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

No closely related category with 50+ devices.

How many gallstone scoop products are registered in the US?

124 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gallstone scoop", from 15 companies. The largest labeler is Sklar Corporation with 20% of records.

Which FDA product codes apply?

FHL (SCOOP), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), FHL (Scoop), FGM (Probe And Director, Gastro-Urology)

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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