ENDOCERVICAL BLOCK NEEDLE
FDA 510(k) clearance K021224 · decided 2002-07-12
Clearance details
- K-number
- K021224
- Device name
- ENDOCERVICAL BLOCK NEEDLE
- Applicant
- Wallach Surgical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-17
- Decision date
- 2002-07-12
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HEE
- Device class
- 2
- Regulation number
- 884.5100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Orange, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (K052365) | Rocket Medical Plc | 2005-10-17 |
| AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (K000117) | Avid Medical, Inc. | 2000-04-13 |
| CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G (K983897) | Ri Mos. S.R.L. | 1999-02-01 |
| GYNEX EXTENDED REACH NEEDLE (K980238) | Gynex Corp. | 1998-08-21 |
| ENDOCERVICAL BLOCK NEEDLE (K973671) | A & A Medical, Inc. | 1997-11-26 |
| ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (K954718) | Ellman Intl., Inc. | 1996-02-29 |
| LEEP REDIKIT (K910253) | CooperSurgical, Inc. | 1991-04-18 |
| POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (K910252) | CooperSurgical, Inc. | 1991-03-04 |
Recalls involving this device
No recalls on record reference this clearance.