HFW — Clamp, Umbilical Class II
FDA product code HFW covers "Clamp, Umbilical", a Class II medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HFW
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041332 | maternus | JOEY CLAMP OPENING TOOL | June 25, 2004 |
| K033846 | kaen yih enterprise co | KAEN YIH UMBILICAL CORD CLAMP | March 11, 2004 |
| K020718 | precision dynamics | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | June 3, 2002 |
| K021055 | busse hospital disposables | BUSSE UMBILICAL CORD CLAMP CUTTER | April 29, 2002 |
| K012917 | dynarex | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | November 28, 2001 |
| K011621 | maternus | KOALA CLAMP, KOALA CLAMP AND CUTTER | August 10, 2001 |
| K010695 | maternus | KOALA CLAMP | May 3, 2001 |
| K010835 | busse hospital disposables | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLA | April 30, 2001 |
| K000227 | pollak (intl.) | UMBICUT | April 27, 2000 |
| K994367 | medical sales | UMBILICAL CORD CLAMP | March 17, 2000 |
| K994263 | precision dynamics | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | January 24, 2000 |
| K990737 | precision dynamics | 'ECURLINE UMBILICAL CORD CLAMP #3500 | April 6, 1999 |
| K983204 | harwill medical (pty) | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP | February 26, 1999 |
| K974227 | gps | HOSPITAL'S CLAMP | December 12, 1997 |
| K963223 | phyllis adams, rn, npc, msn | EZ-CIRC | April 23, 1997 |
| K963889 | qfc industries | QFC UMBILICAL CLAMP | April 18, 1997 |
| K963428 | r.o.s.t. medical development | UMBILICAL CLAMP AND CUTTER | April 1, 1997 |
| K945841 | w g m | BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP | May 30, 1995 |
| K951140 | balagan medical | KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR | May 25, 1995 |
| K933763 | save-t-breath distributors c.c | SAVE-T-BREATH AMBILICAL CORD CLAMP | August 29, 1994 |