Product code HFW
- Device name
- Clamp, Umbilical
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041332 | JOEY CLAMP OPENING TOOL | Maternus, Inc. | 2004-06-25 |
| K033846 | KAEN YIH UMBILICAL CORD CLAMP | Kaen Yih Enterprise Co., Ltd. | 2004-03-11 |
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Precision Dynamics Corp. | 2002-06-03 |
| K021055 | BUSSE UMBILICAL CORD CLAMP CUTTER | Busse Hospital Disposables, Inc. | 2002-04-29 |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Dynarex Corp. | 2001-11-28 |
| K011621 | KOALA CLAMP, KOALA CLAMP AND CUTTER | Maternus, Inc. | 2001-08-10 |
| K010695 | KOALA CLAMP | Maternus, Inc. | 2001-05-03 |
| K010835 | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 | Busse Hospital Disposables, Inc. | 2001-04-30 |
| K000227 | UMBICUT | Pollak (Intl.), Ltd. | 2000-04-27 |
| K994367 | UMBILICAL CORD CLAMP | Medical Sales Co. | 2000-03-17 |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Precision Dynamics Corp. | 2000-01-24 |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Precision Dynamics Corp. | 1999-04-06 |
| K983204 | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP | Harwill Medical (Pty) , Ltd. | 1999-02-26 |
| K974227 | HOSPITAL'S CLAMP | Gps | 1997-12-12 |
| K963223 | EZ-CIRC | Phyllis Adams, Rn, Npc, Msn | 1997-04-23 |
| K963889 | QFC UMBILICAL CLAMP | Qfc Industries | 1997-04-18 |
| K963428 | UMBILICAL CLAMP AND CUTTER | R.O.S.T. Medical Development, Inc. | 1997-04-01 |
| K945841 | BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP | W G M Corp. | 1995-05-30 |
| K951140 | KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR | Balagan Medical, Inc. | 1995-05-25 |
| K933763 | SAVE-T-BREATH AMBILICAL CORD CLAMP | Save-T-Breath Distributors C.C. | 1994-08-29 |
| K934525 | AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER | United States Surgical, A Division of Tyco Healthc | 1994-02-14 |
| K923439 | LUNEAU UMBILICAL CORD CLAMP | Laboratoires Luneau | 1993-05-21 |
| K912419 | CORDGUARD BLOOD COLLECTION DEVICE | O.B. Tech., Inc. | 1992-10-05 |
| K915569 | UMBILICAL CLAMP | Gam Industries, Inc. | 1992-09-23 |
| K912054 | LABOR DELIVERY TRAY | Medical Device Inspection Co., Inc. | 1992-01-21 |
| K912869 | WOMEN AND INFANT'S DELIVERY PACK | Welcon, Inc. | 1991-12-04 |
| K901954 | AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC | Hollister, Inc. | 1990-07-26 |
| K901557 | UMBILICAL CORD CLAMP AND CUTTER | Microtek-Heritage, Inc. | 1990-05-15 |
| K894646 | #556 DISPOSABLE UMBILICAL CORD CLAMP (2) | Alpha Unlimited, Inc. | 1989-09-05 |
| K890382 | COMPRESSION FORCEPS | Kinetic Medical Products | 1989-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10885632431364 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2024-10-30 |
| 30885632431368 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2024-10-30 |
| 00840183513856 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00840113231508 | Double-Grip Umbilical Cord Clamp | ASPEN SURGICAL PRODUCTS, INC. | 2023-02-27 |
| 10840113231512 | Double-Grip Umbilical Cord Clamp | ASPEN SURGICAL PRODUCTS, INC. | 2023-02-27 |
| 10840113231529 | Double-Grip Umbilical Cord Clamp | ASPEN SURGICAL PRODUCTS, INC. | 2023-02-27 |
| 10809160306086 | Halyard | AVID MEDICAL, INC. | 2020-12-10 |
| 20809160306083 | Halyard | AVID MEDICAL, INC. | 2020-12-10 |
| 10080196493401 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-05-18 |
| 40080196493402 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-05-18 |
| 10767056094212 | MABIS DMI | D-M-S HOLDINGS, INC. | 2020-02-17 |
| 10809160173503 | AVID TruCustom | AVID MEDICAL, INC. | 2017-12-15 |
| 10809160153789 | AVID TruCustom | AVID MEDICAL, INC. | 2017-07-07 |
| 50653160021382 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-03-03 |
| 00653160021387 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-03-03 |
| 00653160010619 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-11-30 |
| 50653160010614 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-11-30 |
| 10767506094212 | MABIS DMI | D-M-S HOLDINGS, INC. | 2016-09-23 |
| 10767056094113 | MABIS DMI | D-M-S HOLDINGS, INC. | 2016-09-23 |
| 10767056113852 | MABIS DMI | D-M-S HOLDINGS, INC. | 2016-09-23 |
| 10767056113845 | MABIS DMI | D-M-S HOLDINGS, INC. | 2016-09-23 |
| 10767056094236 | MABIS DMI | D-M-S HOLDINGS, INC. | 2016-09-23 |
| 04038653155040 | AESCULAP | Aesculap AG | 2016-09-23 |
| 10851121007006 | Alpha | ALPHA INDUSTRIES INC | 2016-09-16 |
| 10809160030141 | AVID TruCustom | AVID MEDICAL, INC. | 2016-09-09 |
| 00849233018105 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-01 |
| 00849233013032 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-01 |
| 20849233013036 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-01 |
| 10849233018102 | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. | 2016-09-01 |