FDA product code GDY: Gauze/Sponge, Internal, X-Ray Detectable
GDY is the FDA product code for gauze/sponge, internal, x-ray detectable. It is a Class I device, regulated under 21 CFR 878.4450 and reviewed by the General and Plastic Surgery panel. FDA has cleared 111 510(k) submissions under GDY, from 61 different applicants. The average 510(k) review took 72 days (median 53). FDA has posted 65 recalls for GDY devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class I |
| Regulation | 21 CFR 878.4450 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Top GDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lorrex Health Products | 9 | 1994-12-28 |
| Ultracell Medical Technologies, Inc. | 7 | 1997-12-17 |
| Medical Perspectives Corp. | 7 | 1995-09-14 |
| Thantex Specialties, Inc. | 7 | 1994-12-19 |
| Mcneil Healthcare, Inc. | 5 | 1994-02-03 |
56 more applicants have GDY clearances. See the full list in Caduvo.
Most recent GDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972634 | Ultracell Medical Technologies, Inc. | ULTRACELL SUCTION SPONGE | 1997-12-17 | 156 |
| K960236 | Custom Pack Reliability | CPR LAP SPONGES | 1996-03-28 | 72 |
| K955599 | Stryker Corp. | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | 1996-02-22 | 76 |
| K955322 | Derivados DE Gasa, S.A. DE C.V. | PROTEC X-RAY DETECTABLE GAUZE SPONGE | 1995-12-19 | 29 |
| K953830 | Kentron Health Care, Inc. | KENSORB | 1995-10-03 | 48 |
Recalls for GDY devices
65 product recalls in 17 recall events; 6 initiated in the last five years and 8 still open. Most recent: 2025-07-01.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code GDY?
GDY is the FDA product code for gauze/sponge, internal, x-ray detectable. It is a Class I device, regulated under 21 CFR 878.4450 and reviewed by the General and Plastic Surgery panel.
What device class is GDY?
Class I, regulation 21 CFR 878.4450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDY?
Across 111 cleared submissions the average was 72 days from receipt to decision (median 53).
Which companies have the most GDY clearances?
Lorrex Health Products (9); Ultracell Medical Technologies, Inc. (7); Medical Perspectives Corp. (7); Thantex Specialties, Inc. (7); Mcneil Healthcare, Inc. (5).
Have GDY devices been recalled?
Yes: 65 product recalls across 17 recall events; the most recent began 2025-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GDY
- Run a recall and safety report across every GDY manufacturer
- Watch product code GDY 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.
All General and Plastic Surgery product codes · FDA product code lookup