HEE
9 FDA 510(k) clearances · Product code
86 daysmedian time to decision
210 days90th percentile
9clearances measured
FDA profile
- Official device name
- Set, Anesthesia, Paracervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5100
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (K052365) | Rocket Medical Plc | 2005-10-17 |
| ENDOCERVICAL BLOCK NEEDLE (K021224) | Wallach Surgical Devices, Inc. | 2002-07-12 |
| AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (K000117) | Avid Medical, Inc. | 2000-04-13 |
| CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G (K983897) | Ri Mos. S.R.L. | 1999-02-01 |
| GYNEX EXTENDED REACH NEEDLE (K980238) | Gynex Corp. | 1998-08-21 |
| ENDOCERVICAL BLOCK NEEDLE (K973671) | A & A Medical, Inc. | 1997-11-26 |
| ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (K954718) | Ellman Intl., Inc. | 1996-02-29 |
| LEEP REDIKIT (K910253) | CooperSurgical, Inc. | 1991-04-18 |
| POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (K910252) | CooperSurgical, Inc. | 1991-03-04 |
Track HEE automatically
Every clearance here is in the API, with alerts when new ones post.