Panels › Obstetrics/Gynecology › Product code HEE · Class 2
Set, Anesthesia, Paracervical
Regulation 884.5100
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HEE
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 2 | 1 |
| A & A Medical, Inc. | 1 | 0 |
| Avid Medical, Inc. | 1 | 0 |
| Ellman Intl., Inc. | 1 | 0 |
| Gynex Corp. | 1 | 0 |
| Ri Mos. S.R.L. | 1 | 0 |
| Rocket Medical Plc | 1 | 0 |
| Wallach Surgical Devices, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2005 | K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE Rocket Medical Plc, GB | HEE |
| Jul 12, 2002 | K021224 | ENDOCERVICAL BLOCK NEEDLE Wallach Surgical Devices, Inc. | HEE |
| Apr 13, 2000 | K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE Avid Medical, Inc. | HEE |
| Feb 1, 1999 | K983897 | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G Ri Mos. S.R.L. | HEE |
| Aug 21, 1998 | K980238 | GYNEX EXTENDED REACH NEEDLE Gynex Corp. | HEE |
| Nov 26, 1997 | K973671 | ENDOCERVICAL BLOCK NEEDLE A & A Medical, Inc. | HEE |
| Feb 29, 1996 | K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE Ellman Intl., Inc. | HEE |
| Apr 18, 1991 | K910253 | LEEP REDIKIT CooperSurgical, Inc. | HEE |
| Mar 4, 1991 | K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE CooperSurgical, Inc. | HEE |
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