GDL
5 FDA 510(k) clearances · Product code
56 daysmedian time to decision
62 days90th percentile
5clearances measured
FDA profile
- Official device name
- Needle, Suturing, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NON-STERILE SUTURE NEEDLES (K881394) | China National Medicines C/O Havel'S | 1988-04-08 |
| 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES (K851781) | Artiberia | 1985-06-20 |
| 25-450 TO 25-540 VARIOUS SUTURE FORCEPS (K851782) | Artiberia | 1985-06-20 |
| SHARTPOINT EYED NEEDLES (K813589) | S. Jackson, Inc. | 1982-01-18 |
| UNIVERSAL SUTURE PASSER (K812566) | Ortho Pared Instruments, Inc. | 1981-11-10 |
Track GDL automatically
Every clearance here is in the API, with alerts when new ones post.