FDA product code GAD: Retractor
GAD is the FDA product code for retractor. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 100 510(k) submissions under GAD, from 70 different applicants. The average 510(k) review took 74 days (median 34). FDA has posted 44 recalls for GAD devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retractor |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 GAD clearance
Top GAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| T. Korossurgical Instruments Corp. | 8 | 1993-08-06 |
| Edward Weck, Inc. | 4 | 1980-08-04 |
| Medin Corp. | 3 | 1993-07-02 |
| Karlin Technology, Inc. | 3 | 1990-09-05 |
| Kinetic Medical Products | 3 | 1989-01-27 |
65 more applicants have GAD clearances. See the full list in Caduvo.
Most recent GAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152538 | J.R. Parker, LLC | JRP Wound Spreader | 2016-04-13 | 222 |
| K151104 | Spineart | OTELO LL | 2016-01-06 | 257 |
| K132645 | Medtronic, Inc. | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | 2013-10-04 | 42 |
| K071775 | Ezsurgical | DASH | 2007-08-07 | 39 |
| K050256 | Apple Medical Corp. | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | 2005-04-26 | 82 |
Recalls for GAD devices
44 product recalls in 29 recall events; 10 initiated in the last five years and 11 still open. Most recent: 2026-06-05.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GAD?
GAD is the FDA product code for retractor. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GAD?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAD?
Across 100 cleared submissions the average was 74 days from receipt to decision (median 34).
Which companies have the most GAD clearances?
T. Korossurgical Instruments Corp. (8); Edward Weck, Inc. (4); Medin Corp. (3); Karlin Technology, Inc. (3); Kinetic Medical Products (3).
Have GAD devices been recalled?
Yes: 44 product recalls across 29 recall events; the most recent began 2026-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code GAD
- Run a recall and safety report across every GAD manufacturer
- Watch product code GAD 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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