HURWITZ AMNIOCENTESIS NEEDLE
FDA 510(k) clearance K854725 · decided 1986-03-17
Clearance details
- K-number
- K854725
- Device name
- HURWITZ AMNIOCENTESIS NEEDLE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1985-11-22
- Decision date
- 1986-03-17
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- HIO
- Device class
- 1
- Regulation number
- 884.1550
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Paramus, NJ, 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 |
|---|---|---|
| G.E. STERILE AMNIOCENTESIS TRAY (K960203) | GE Medical Systems | 1996-03-14 |
| RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (K955679) | Contour Fabricators of Florida, Inc. | 1996-03-12 |
| AMNIOTEST(TM) (K914419) | Pro-Lab, Inc. | 1993-09-01 |
| VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960) | Cameo, Inc. | 1992-11-05 |
| SONO-VU US(TM), MODIFICATION (K921738) | E-Z-Em, Inc. | 1992-04-27 |
| MEGA AMNIOCENTESIS KIT (K915863) | Mega Medical, Inc. | 1992-03-30 |
| SONO-VU US(TM) (K904583) | E-Z-Em, Inc. | 1991-06-24 |
| ISOFLO(TM) AMNIOCENTESIS TRAY (K901643) | Healthdyne Cardiovascular, Inc. | 1990-07-25 |
| PERCU-SET(TM) (K900021) | E-Z-Em, Inc. | 1990-03-29 |
| AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (K896031) | Concord/Portex | 1990-01-12 |
| PHARMASEAL GENETIC AMNIOCENTESIS TRAY (K894031) | Baxter Healthcare Corp | 1989-08-04 |
| ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE (K892846) | Cook Ob/Gyn | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |