FDA product code GDO: Applier, Surgical, Clip
GDO is the FDA product code for applier, surgical, clip. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under GDO, from 8 different applicants. The average 510(k) review took 43 days (median 28). FDA has posted 8 recalls for GDO devices.
Classification
| Field | Value |
|---|---|
| Device name | Applier, Surgical, Clip |
| 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 GDO clearance
Top GDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 4 | 1979-12-06 |
| ETHICON, Inc. | 3 | 1982-05-28 |
| United States Surgical, A Division of Tyco Healthc | 2 | 1989-04-07 |
| Unisurge, Inc. | 1 | 1993-04-20 |
| Dhason Brothers, Inc. | 1 | 1989-02-03 |
3 more applicants have GDO clearances. See the full list in Caduvo.
Most recent GDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926199 | Unisurge, Inc. | UNICLIP SURGICAL CLIP APPLIER | 1993-04-20 | 132 |
| K890941 | United States Surgical, A Division of Tyco Healthc | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP | 1989-04-07 | 43 |
| K890159 | Dhason Brothers, Inc. | TOWEL CLIPS | 1989-02-03 | 25 |
| K890233 | Kinetic Medical Products | SUTURE CLIP APPLIER/REMOVER | 1989-01-27 | 9 |
| K820837 | ETHICON, Inc. | DISPOSABLE MULTIPLE LIGATING CLIP | 1982-05-28 | 63 |
Recalls for GDO devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-24.
Frequently asked questions
What is FDA product code GDO?
GDO is the FDA product code for applier, surgical, clip. 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 GDO?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDO?
Across 14 cleared submissions the average was 43 days from receipt to decision (median 28).
Which companies have the most GDO clearances?
Edward Weck, Inc. (4); ETHICON, Inc. (3); United States Surgical, A Division of Tyco Healthc (2); Unisurge, Inc. (1); Dhason Brothers, Inc. (1).
Have GDO devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2016-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GDO
- Run a recall and safety report across every GDO manufacturer
- Watch product code GDO 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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