Product code HEE— Obstetrics/Gynecology
ENDOCERVICAL BLOCK NEEDLE
- Classification name
- Set, Anesthesia, Paracervical
- Device class
- Class 2
- Regulation
- 21 CFR 884.5100
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code HEE
FDA has cleared devices under product code HEE between 1991 and 2005, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
- 1991
Top applicants under product code HEE
Recent clearances under product code HEE
- K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
- K021224 — ENDOCERVICAL BLOCK NEEDLE
- K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
- K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
- K980238 — GYNEX EXTENDED REACH NEEDLE
- K973671 — ENDOCERVICAL BLOCK NEEDLE
- K954718 — ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
- K910253 — LEEP REDIKIT
- K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.