GBLNot classified

Catheter, Ureteral, General & Plastic Surgery

21 CFR 876.5130 / Gastroenterology, Urology

GBL is the FDA product code for Catheter, Ureteral, General & Plastic Surgery, regulated under 21 CFR 876.5130. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code: GBL
Device name: Catheter, Ureteral, General & Plastic Surgery
Regulation: 21 CFR 876.5130
Device class: Not classified
Review panel: Gastroenterology, Urology
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 2

Companies listing this code with FDA

Companies whose registered establishments list this code

Allwin Medical Devices, Inc.

Recent clearances

Product code GBL

FDA records hold no clearances under product code GBL.

Recent recalls

Product code GBL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)