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Device Explorer · FDA GUDID · GMDN 46729

Tissue morcellation system

An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It

US‑registered devices109in commercial distribution
Companies10labelers on GUDID
Single‑use47%of device records
Sterile46%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg5651%
Trokamed Gmbh1312%
Lumenis Ltd.109%
Covidien Lp98%
Hologic, Inc.76%
Nico Corporation55%
Richard Wolf Gmbh44%
Asclepion Laser Technologies Gmbh33%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg5651%
Trokamed Gmbh1312%
Lumenis Ltd.109%
Covidien Lp98%
Hologic, Inc.76%
Nico Corporation55%
Richard Wolf Gmbh44%
Asclepion Laser Technologies Gmbh33%
Polygon Medical Inc11%
Eon Meditech Private Limited11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Versacut™VersaCut+ Sterile Outer BladeVersaCut Sterile Outer BladeVersaCut Sterile Inner BladeVersaCut™VersaCut+ Blade SetAspiration Disposables KitVersacut Tissue MorcellatorAspiration TubeVersaCut Blade SetBLUEENDOMultiCut Blade 400MultiCut Blade 350MultiCut SoloPIRANHAE-LINE

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

FDA product codes

CodeNameDevices
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP43
HIHHYSTEROSCOPE (AND ACCESSORIES)19
GCJLaparoscope, General & Plastic Surgery13
HETLaparoscope, Gynecologic (And Accessories)13
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)10
GCJLaparoscope, general & plastic surgery7

GMDN & GCC registration

  • GMDN code 46729 · non‑implantable
  • Single‑use 47% · sterile 46% · Rx‑only 95% · 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

Outer Diameter (Millimeter) · 11Length (Millimeter) · 7Lumen/Inner Diameter (Millimeter) · 1

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

How many tissue morcellation system products are registered in the US?

109 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tissue morcellation system", from 10 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 51% of records.

Which FDA product codes apply?

ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP), HIH (HYSTEROSCOPE (AND ACCESSORIES)), GCJ (Laparoscope, General & Plastic Surgery), HET (Laparoscope, Gynecologic (And Accessories))

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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