FDA product code GAB: Needle, Suturing, Disposable
GAB is the FDA product code for needle, suturing, disposable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under GAB, from 8 different applicants. The average 510(k) review took 91 days (median 70). FDA has posted 7 recalls for GAB devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Suturing, Disposable |
| 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 GAB clearance
Top GAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Humana USA, Inc. | 1 | 2001-12-19 |
| Axya Medical, Inc. | 1 | 1998-05-11 |
| Synergistic Medical Technologies, Inc. | 1 | 1993-12-22 |
| Applied Medical Technologies | 1 | 1989-10-24 |
| Sharpoint, Inc. | 1 | 1986-10-24 |
3 more applicants have GAB clearances. See the full list in Caduvo.
Most recent GAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012199 | Humana USA, Inc. | DIGICAP | 2001-12-19 | 159 |
| K980988 | Axya Medical, Inc. | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | 1998-05-11 | 55 |
| K932591 | Synergistic Medical Technologies, Inc. | ENDO-JUDGE | 1993-12-22 | 208 |
| K895681 | Applied Medical Technologies | CONTRAST BACKGROUND MATERIAL | 1989-10-24 | 33 |
| K863595 | Sharpoint, Inc. | COATED SUTURE NEEDLE | 1986-10-24 | 39 |
Recalls for GAB devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-24.
| Year | Recalls |
|---|---|
| 2018 | 6 |
Frequently asked questions
What is FDA product code GAB?
GAB is the FDA product code for needle, suturing, disposable. 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 GAB?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAB?
Across 8 cleared submissions the average was 91 days from receipt to decision (median 70).
Which companies have the most GAB clearances?
Humana USA, Inc. (1); Axya Medical, Inc. (1); Synergistic Medical Technologies, Inc. (1); Applied Medical Technologies (1); Sharpoint, Inc. (1).
Have GAB devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2018-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GAB
- Run a recall and safety report across every GAB manufacturer
- Watch product code GAB 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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