HFC
11 FDA 510(k) clearances · Product code
82 daysmedian time to decision
187 days90th percentile
11clearances measured
FDA profile
- Official device name
- Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 2005: 7
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 |
|---|---|---|
| ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR (K974032) | A & A Medical, Inc. | 1997-12-22 |
| CERVICAL MUCOUS ASPIRATION CATHETER (K960263) | Cook Urological, Inc. | 1996-08-29 |
| PEDI VAGINAL ASPIRATOR (K954903) | Cook Urological, Inc. | 1996-04-29 |
| SELECTMUCUS (K954102) | Select Medical Systems, Inc. | 1995-11-21 |
| ENDOCERVICAL ASPIRATOR (K902242) | Innovative Medical Products, Inc. | 1990-10-09 |
| O. B. PACK IV (K902032) | Customed, Inc. | 1990-09-28 |
| OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (K902954) | Permobil AB | 1990-08-23 |
| ASPIRETTE ENDOCERVICAL ASPIRATOR (K895403) | Unimar, Inc. | 1989-11-29 |
| DC PACK TM (K821134) | Seamless Hospital Products Co. | 1982-06-22 |
| ENDOCERVICAL ASPIRATOR (K812175) | Fertility Instrumentation, Inc. | 1981-09-21 |
| ACCU-PAP T ZONE SAMPLER (K801238) | Robert Hasselbrack, M.D. | 1980-08-12 |
Track HFC automatically
Every clearance here is in the API, with alerts when new ones post.