GBQ
8 FDA 510(k) clearances · Product code
39 daysmedian time to decision
74 days90th percentile
8clearances measured
FDA profile
- Official device name
- Catheter, Continuous Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 2 · 1993: 1 · 2023: 32
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 |
|---|---|---|
| MICROFLOW IRRIGATION SYSTEM (K941356) | Jedmed Instrument Co. | 1994-05-19 |
| CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (K921464) | Trinity Laboratories, Inc. | 1992-05-05 |
| GESCO CATHETERIZATION TRAY (K882647) | Gesco Intl., Inc. | 1988-09-09 |
| PERFORATED SOAKING TUBE (K874596) | Specialty Medical Products Co. | 1987-12-02 |
| PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (K873097) | Ipax, Inc. | 1987-09-04 |
| MODIFIED CURLCATH (K872787) | Quinton, Inc. | 1987-08-04 |
| GASTRIC LAVAGE KIT-DISPOSABLE (K791400) | Acumed Instruments Corp. | 1979-08-16 |
| THORNTON ANTERIOR CHAMBER IRRIGATOR (K771732) | Concept, Inc. | 1977-09-28 |
Track GBQ automatically
Every clearance here is in the API, with alerts when new ones post.