Product code GDT
- Device name
- Staple, Removable (Skin)
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4760
- Review panel
- SU
- 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 |
|---|---|---|---|
| K963234 | STAPLE REMOVAL KIT | Continental Medical Laboratories, Inc. | 1996-10-21 |
| K943719 | VISISTAT STAPLER | Pilling Weck, Inc. | 1994-08-24 |
| K925526 | MANIPLER DISPOSABLE SKIN STAPLER | Matsutani Seisakusho Co. , Ltd. | 1993-06-24 |
| K915430 | SKIN STAPLE REMOVER KIT | Cypress Medical Products, Ltd. | 1992-02-28 |
| K911204 | QUALTEX SKIN STAPLE EXTRACTOR | Deroyal Industries, Inc. | 1991-05-08 |
| K910586 | AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* | United States Surgical, A Division of Tyco Healthc | 1991-03-07 |
| K900486 | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER | Davis & Geck, Inc. | 1990-04-20 |
| K861711 | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | Busse Hospital Disposables, Inc. | 1986-05-16 |
| K851974 | V. MUELLER VITAL SKIN STAPLER | American V. Mueller | 1985-06-11 |
| K844838 | SKIN STAT II SKIN STAPLING MEDICAL DEVICE | Edward Weck, Inc. | 1985-01-23 |
| K844837 | VISISTAT SKIN STAPLING DEVICE | Edward Weck, Inc. | 1985-01-23 |
| K833085 | STAPLE REMOVER SR300P | Prosper, Inc. | 1984-12-14 |
| K833357 | VYDAX 525-550 & 5100 FLUOROTELOMER | ETHICON, Inc. | 1983-12-12 |
| K832709 | SKIN STAPLING DEVICE SC2000 | Prosper, Inc. | 1983-09-26 |
| K822365 | CENTURION SKIN STAPLE REMOVER | Tri-State | 1982-08-27 |
| K821024 | DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE | Howmedica Corp. | 1982-05-14 |
| K801444 | SKIN STAPLE REMOVER #523770 | Edward Weck, Inc. | 1980-07-14 |
| K800535 | 3M DISPOSABLE SKIN STAPLER | 3M Company | 1980-04-04 |
| K760734 | REGULAR AND WIDE SKIN STAPLES | ETHICON, Inc. | 1976-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344111053 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-03-05 |
| 10080196846924 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2025-02-16 |
| 10841767102944 | Trinity Sterile, Inc. | Trinity Sterile, Inc. | 2023-03-09 |
| 10801902192070 | ARROW | TELEFLEX INCORPORATED | 2022-11-29 |
| 10195327227715 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-28 |
| 10195327234539 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-28 |
| 10653405037101 | REFLEX | Conmed Corporation | 2020-11-21 |
| 10612479226880 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-09 |
| 10612479226903 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-04-09 |
| 10884521104365 | Appose ULC | Covidien LP | 2019-02-13 |
| 10884521104372 | Appose ULC | Covidien LP | 2018-10-18 |
| 10884521080690 | Multifire Premium | Covidien LP | 2018-08-19 |
| 10884521080737 | SM | Covidien LP | 2018-08-10 |
| 10884521080720 | SM | Covidien LP | 2018-08-10 |
| 10884521080706 | Multifire Premium | Covidien LP | 2018-08-10 |
| 10884521080751 | Auto Suture | Covidien LP | 2018-08-10 |
| 10884521080669 | Signet | Covidien LP | 2018-08-10 |
| 10884521080676 | Multifire Premium | Covidien LP | 2018-08-10 |
| 10884521080683 | Multifire Premium | Covidien LP | 2018-08-10 |
| 10381780258889 | Omnigraft™ | Integra Lifesciences Corporation | 2017-02-01 |
| 10885403273568 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10705036013020 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036013013 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036002673 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036002666 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036002642 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10705036002635 | Proximate | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |
| 10885425324118 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-07-07 |
| 10381780125792 | Omnigraft™ | Integra Lifesciences Corporation | 2016-05-11 |
| 10381780125754 | Omnigraft™ | Integra Lifesciences Corporation | 2016-05-11 |