FDA product code GDL: Needle, Suturing, Reusable
GDL is the FDA product code for needle, suturing, reusable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under GDL, from 4 different applicants. The average 510(k) review took 40 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Suturing, Reusable |
| 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 GDL clearance
Top GDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 2 | 1985-06-20 |
| China National Medicines C/O Havel'S | 1 | 1988-04-08 |
| S. Jackson, Inc. | 1 | 1982-01-18 |
| Ortho Pared Instruments, Inc. | 1 | 1981-11-10 |
Most recent GDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881394 | China National Medicines C/O Havel'S | NON-STERILE SUTURE NEEDLES | 1988-04-08 | 4 |
| K851782 | Artiberia | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | 1985-06-20 | 56 |
| K851781 | Artiberia | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | 1985-06-20 | 56 |
| K813589 | S. Jackson, Inc. | SHARTPOINT EYED NEEDLES | 1982-01-18 | 21 |
| K812566 | Ortho Pared Instruments, Inc. | UNIVERSAL SUTURE PASSER | 1981-11-10 | 62 |
Recalls for GDL devices
openFDA lists no recalls for product code GDL.
Frequently asked questions
What is FDA product code GDL?
GDL is the FDA product code for needle, suturing, reusable. 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 GDL?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDL?
Across 5 cleared submissions the average was 40 days from receipt to decision (median 56).
Which companies have the most GDL clearances?
Artiberia (2); China National Medicines C/O Havel'S (1); S. Jackson, Inc. (1); Ortho Pared Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GDL
- Run a recall and safety report across every GDL manufacturer
- Watch product code GDL 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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