HDQ
6 FDA 510(k) clearances · Product code
43 daysmedian time to decision
415 days90th percentile
6clearances measured
FDA profile
- Official device name
- Dilator, Cervical, Fixed Size
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1999: 2 · 2000: 1 · 2001: 1 · 2006: 3
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 |
|---|---|---|
| CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (K930034) | Thomasville Medical Assoc. | 1994-02-24 |
| TEFLON CERVICAL ACCESS SET (K896701) | Cook Ob/Gyn | 1990-09-13 |
| CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (K891029) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| FIXED-SIZE UTERINE DILATOR (K890377) | Kinetic Medical Products | 1989-02-13 |
| CERVICAL DILATOR (K811568) | Gynemetrics, Inc. | 1981-07-16 |
| MODEL 6500 EXTRACTION IRRIGATION SYS (K791277) | Cavitron Corp. | 1979-08-22 |
Track HDQ automatically
Every clearance here is in the API, with alerts when new ones post.