Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Open-surgery biopsy forceps, reusable
Device Explorer · FDA GUDID · GMDN 11775

Open-surgery biopsy forceps, reusable

A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or cathet

US‑registered devices2,599in commercial distribution
Companies53labelers on GUDID
Single‑use42%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Novo Surgical, Inc.1,14844%
Avalign Technologies, Inc.33813%
Surtex Instruments Ltd.1295%
Integra Lifesciences Production Corporation964%
Teleflex Incorporated723%
Hayden Medical, Inc.703%
American Medical Endoscopy, Inc.673%
Gynex Corporation642%

Top labelers

CompanyDevicesShare
Novo Surgical, Inc.1,14844%
Avalign Technologies, Inc.33813%
Surtex Instruments Ltd.1295%
Integra Lifesciences Production Corporation964%
Teleflex Incorporated723%
Hayden Medical, Inc.703%
American Medical Endoscopy, Inc.673%
Gynex Corporation642%
George Tiemann & Co.552%
Surgical Direct, Inc.532%
Sontec Instruments, Inc.422%
Br Surgical, Llc402%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NASurtexN/ALAZICFENTEXForcepsHermann Medizintechnik GmbHevonosRZ Medizintechnik GmbHGimmiSilGraspROBIMEDIAFITRHINOFORCEn.a.CLICKLINE

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

FDA product codes

CodeNameDevices
GENForceps, General & Plastic Surgery501
HCZFORCEPS, SURGICAL, GYNECOLOGICAL262
HFBFORCEPS, BIOPSY, GYNECOLOGICAL231
KAEForceps, Ent228
FCLFORCEPS, BIOPSY, NON-ELECTRIC220
HFBForceps, Biopsy, Gynecological183

GMDN & GCC registration

  • GMDN code 11775 · non‑implantable
  • Single‑use 42% · sterile 0% · Rx‑only 80% · 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) · 147Length (Millimeter) · 73Width (Millimeter) · 53Length (Centimeter) · 45Angle (degree) · 8Outer Diameter (Millimeter) · 4

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

How many open-surgery biopsy forceps, reusable products are registered in the US?

2,599 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery biopsy forceps, reusable", from 53 companies. The largest labeler is Novo Surgical, Inc. with 44% of records.

Which FDA product codes apply?

GEN (Forceps, General & Plastic Surgery), HCZ (FORCEPS, SURGICAL, GYNECOLOGICAL), HFB (FORCEPS, BIOPSY, GYNECOLOGICAL), KAE (Forceps, Ent)

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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