KAEN YIH UMBILICAL CORD CLAMP
FDA 510(k) clearance K033846 · decided 2004-03-11
Clearance details
- K-number
- K033846
- Device name
- KAEN YIH UMBILICAL CORD CLAMP
- Applicant
- Kaen Yih Enterprise Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-11
- Decision date
- 2004-03-11
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- HFW
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mc Henry, IL, 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 |
|---|---|---|
| JOEY CLAMP OPENING TOOL (K041332) | Maternus, Inc. | 2004-06-25 |
| SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (K020718) | Precision Dynamics Corp. | 2002-06-03 |
| BUSSE UMBILICAL CORD CLAMP CUTTER (K021055) | Busse Hospital Disposables, Inc. | 2002-04-29 |
| DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (K012917) | Dynarex Corp. | 2001-11-28 |
| KOALA CLAMP, KOALA CLAMP AND CUTTER (K011621) | Maternus, Inc. | 2001-08-10 |
| KOALA CLAMP (K010695) | Maternus, Inc. | 2001-05-03 |
| POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 (K010835) | Busse Hospital Disposables, Inc. | 2001-04-30 |
| UMBICUT (K000227) | Pollak (Intl.), Ltd. | 2000-04-27 |
| UMBILICAL CORD CLAMP (K994367) | Medical Sales Co. | 2000-03-17 |
| SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (K994263) | Precision Dynamics Corp. | 2000-01-24 |
| 'ECURLINE UMBILICAL CORD CLAMP #3500 (K990737) | Precision Dynamics Corp. | 1999-04-06 |
| HARWILL MEDICAL U-KLIP UMBILICAL CLAMP (K983204) | Harwill Medical (Pty) , Ltd. | 1999-02-26 |
Recalls involving this device
No recalls on record reference this clearance.