FDA product code GBW: Catheter, Peritoneal
GBW is the FDA product code for catheter, peritoneal. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under GBW, from 12 different applicants. The average 510(k) review took 117 days (median 62). FDA has posted 15 recalls for GBW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Peritoneal |
| 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 GBW clearance
Top GBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 4 | 1996-08-08 |
| Taut, Inc. | 3 | 1999-10-05 |
| Medical Components, Inc. | 1 | 1996-03-21 |
| Sherwood Medical Co. | 1 | 1994-02-24 |
| Core Dynamics, Inc. | 1 | 1993-11-12 |
7 more applicants have GBW clearances. See the full list in Caduvo.
Most recent GBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992904 | Taut, Inc. | MINI-PORT | 1999-10-05 | 36 |
| K992907 | Taut, Inc. | INTRADUCER | 1999-10-05 | 36 |
| K972112 | Taut, Inc. | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | 1997-12-01 | 179 |
| K961194 | Sil-Med Corp. | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | 1996-08-08 | 134 |
| K960426 | Medical Components, Inc. | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | 1996-03-21 | 52 |
Recalls for GBW devices
15 product recalls in 9 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GBW?
GBW is the FDA product code for catheter, peritoneal. 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 GBW?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBW?
Across 17 cleared submissions the average was 117 days from receipt to decision (median 62).
Which companies have the most GBW clearances?
Sil-Med Corp. (4); Taut, Inc. (3); Medical Components, Inc. (1); Sherwood Medical Co. (1); Core Dynamics, Inc. (1).
Have GBW devices been recalled?
Yes: 15 product recalls across 9 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GBW
- Run a recall and safety report across every GBW manufacturer
- Watch product code GBW 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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