510(k) K021224
- Device
- ENDOCERVICAL BLOCK NEEDLE
- Applicant
- WALLACH SURGICAL DEVICES, INC.
- 510(k) number
- K021224
- Product code
- HEE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-12
- Date received
- 2002-04-17
- Regulation
- 884.5100
- Classification name
- Set, Anesthesia, Paracervical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL MALIS
- Address
- 235 Edison Rd. Orange CT US 06477 06477
FDA Registration Numbers#
- 1423507
- 1224960
- 1216677
- 3032109
- 3010155661
- 1222993
- 2245304
- 3009401905
Source Documents#
Other 510(k) Records For Product Code HEE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Rocket Medical Plc | 2005-10-17 |
| K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | Avid Medical, Inc. | 2000-04-13 |
| K983897 | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G | Ri Mos. S.R.L. | 1999-02-01 |
| K980238 | GYNEX EXTENDED REACH NEEDLE | Gynex Corp. | 1998-08-21 |
| K973671 | ENDOCERVICAL BLOCK NEEDLE | A & A Medical, Inc. | 1997-11-26 |
| K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE | Ellman Intl., Inc. | 1996-02-29 |
| K910253 | LEEP REDIKIT | CooperSurgical, Inc. | 1991-04-18 |
| K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE | CooperSurgical, Inc. | 1991-03-04 |
Legacy Summary#
summary
FDA Review#
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