510(k) K980238
- Device
- GYNEX EXTENDED REACH NEEDLE
- Applicant
- GYNEX CORP.
- 510(k) number
- K980238
- Product code
- HEE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-21
- Date received
- 1998-01-23
- 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
- DAVID W SCHLERF
- Address
- 1000 Burnett Ave., Suite 450 Concord CA US 94520 94520
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 |
| K021224 | ENDOCERVICAL BLOCK NEEDLE | Wallach Surgical Devices, Inc. | 2002-07-12 |
| 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 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases