FDA product code GBZ: Catheter, Cholangiography
GBZ is the FDA product code for catheter, cholangiography. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 24 510(k) submissions under GBZ, from 21 different applicants. The average 510(k) review took 112 days (median 84). FDA has posted 27 recalls for GBZ devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Cholangiography |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBZ clearance
Top GBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources | 3 | 1994-11-29 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1993-07-07 |
| Nashville Surgical Instruments | 1 | 1997-12-17 |
| Ethicon Endo-Surgery, Inc. | 1 | 1994-08-05 |
| Boston Scientific Corp | 1 | 1993-08-10 |
16 more applicants have GBZ clearances. See the full list in Caduvo.
Most recent GBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973621 | Nashville Surgical Instruments | PRE-VIEW CHOLANGIOGRAPHY CLAMP | 1997-12-17 | 85 |
| K944790 | Applied Medical Resources | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | 1994-11-29 | 62 |
| K942450 | Ethicon Endo-Surgery, Inc. | ENDOPATH | 1994-08-05 | 74 |
| K932228 | Boston Scientific Corp | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER | 1993-08-10 | 95 |
| K926217 | Terumo Medical Corp. | TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE | 1993-07-13 | 215 |
Recalls for GBZ devices
27 product recalls in 11 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-08-07.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code GBZ?
GBZ is the FDA product code for catheter, cholangiography. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBZ?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBZ?
Across 24 cleared submissions the average was 112 days from receipt to decision (median 84).
Which companies have the most GBZ clearances?
Applied Medical Resources (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Nashville Surgical Instruments (1); Ethicon Endo-Surgery, Inc. (1); Boston Scientific Corp (1).
Have GBZ devices been recalled?
Yes: 27 product recalls across 11 recall events; the most recent began 2026-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code GBZ
- Run a recall and safety report across every GBZ manufacturer
- Watch product code GBZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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