FDA product code GDT: Staple, Removable (Skin)
GDT is the FDA product code for staple, removable (skin). It is a Class I device, regulated under 21 CFR 878.4760 and reviewed by the General and Plastic Surgery panel. FDA has cleared 19 510(k) submissions under GDT, from 15 different applicants. The average 510(k) review took 74 days (median 42). FDA has posted 5 recalls for GDT devices.
Classification
| Field | Value |
|---|---|
| Device name | Staple, Removable (Skin) |
| Device class | Class I |
| Regulation | 21 CFR 878.4760 |
| 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 GDT clearance
Top GDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 3 | 1985-01-23 |
| Prosper, Inc. | 2 | 1984-12-14 |
| ETHICON, Inc. | 2 | 1983-12-12 |
| Continental Medical Laboratories, Inc. | 1 | 1996-10-21 |
| Pilling Weck, Inc. | 1 | 1994-08-24 |
10 more applicants have GDT clearances. See the full list in Caduvo.
Most recent GDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963234 | Continental Medical Laboratories, Inc. | STAPLE REMOVAL KIT | 1996-10-21 | 63 |
| K943719 | Pilling Weck, Inc. | VISISTAT STAPLER | 1994-08-24 | 23 |
| K925526 | Matsutani Seisakusho Co. , Ltd. | MANIPLER DISPOSABLE SKIN STAPLER | 1993-06-24 | 234 |
| K915430 | Cypress Medical Products, Ltd. | SKIN STAPLE REMOVER KIT | 1992-02-28 | 88 |
| K911204 | Deroyal Industries, Inc. | QUALTEX SKIN STAPLE EXTRACTOR | 1991-05-08 | 50 |
Recalls for GDT devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code GDT?
GDT is the FDA product code for staple, removable (skin). It is a Class I device, regulated under 21 CFR 878.4760 and reviewed by the General and Plastic Surgery panel.
What device class is GDT?
Class I, regulation 21 CFR 878.4760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDT?
Across 19 cleared submissions the average was 74 days from receipt to decision (median 42).
Which companies have the most GDT clearances?
Edward Weck, Inc. (3); Prosper, Inc. (2); ETHICON, Inc. (2); Continental Medical Laboratories, Inc. (1); Pilling Weck, Inc. (1).
Have GDT devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2018-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code GDT
- Run a recall and safety report across every GDT manufacturer
- Watch product code GDT 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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