HEE · Class II · 21 CFR 884.5100

FDA Product Code HEE: Set, Anesthesia, Paracervical

Leading manufacturers include CooperSurgical, Inc., Wallach Surgical Devices, Inc. and Rocket Medical Plc.

9
Total
9
Cleared
95d
Avg days
1991
Since

FDA 510(k) Cleared Set, Anesthesia, Paracervical Devices (Product Code HEE)

9 devices
1–9 of 9
Cleared Oct 17, 2005
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
K052365
Rocket Medical Plc
Obstetrics & Gynecology · 49d
Cleared Jul 12, 2002
ENDOCERVICAL BLOCK NEEDLE
K021224
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 86d
Cleared Feb 01, 1999
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
K983897
Ri Mos. S.R.L.
Obstetrics & Gynecology · 90d
Cleared Aug 21, 1998
GYNEX EXTENDED REACH NEEDLE
K980238
Gynex Corp.
Obstetrics & Gynecology · 210d
Cleared Nov 26, 1997
ENDOCERVICAL BLOCK NEEDLE
K973671
A & A Medical, Inc.
Obstetrics & Gynecology · 61d
Cleared Feb 29, 1996
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
K954718
Ellman Intl., Inc.
Obstetrics & Gynecology · 139d
Cleared Apr 18, 1991
LEEP REDIKIT
K910253
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 04, 1991
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
K910252
CooperSurgical, Inc.
Obstetrics & Gynecology · 41d

About Product Code HEE - Regulatory Context