Product code KGS
- Device name
- Retention Device, Suture
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4930
- 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 |
|---|---|---|---|
| K030031 | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | 2003-01-28 |
| K020480 | RBM | Smith & Nephew, Inc. | 2002-03-12 |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | 1997-02-25 |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | 1995-06-30 |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | 1993-11-09 |
| K904435 | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | 1991-08-29 |
| K911225 | TRAY DOUGH | The Hygenic Corp. | 1991-04-17 |
| K904136 | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | 1990-10-02 |
| K902001 | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | 1990-05-09 |
| K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | 1989-11-20 |
| K893995 | DERMACARE TIE HOLDER | Dermacare | 1989-08-11 |
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | 1989-02-27 |
| K883299 | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | 1987-09-16 |
| K863570 | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | 1986-09-29 |
| K832138 | BIOMER * PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | 1984-05-23 |
| K813581 | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | 1982-03-23 |
| K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | ETHICON, Inc. | 1981-11-20 |
| K792004 | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | 1979-11-05 |
| K771554 | SUTURE RETENTION CLAMP | Concept, Inc. | 1977-09-02 |
Related GUDID Devices#
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|---|---|---|---|
| 10888277381766 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-01-03 |
| 10884450786199 | Perchik Button™ | Merit Medical Systems, Inc. | 2024-07-02 |
| 00630094199894 | Bioseal Inc. | BIOSEAL | 2023-12-19 |
| 00630094199870 | Bioseal Inc. | BIOSEAL | 2023-12-19 |
| 00630094199863 | Bioseal Inc. | BIOSEAL | 2023-12-19 |
| 00630094199832 | Bioseal Inc. | BIOSEAL | 2023-12-19 |
| 00630094199818 | Bioseal Inc. | BIOSEAL | 2023-12-19 |
| 00630094997322 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094997254 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199801 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199788 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199757 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199733 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199719 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199313 | Bioseal Inc. | BIOSEAL | 2023-12-11 |
| 00630094194493 | Bioseal Inc. | BIOSEAL | 2023-10-11 |
| 00630094194684 | Bioseal Inc. | BIOSEAL | 2023-10-11 |
| 00630094192413 | Bioseal Inc. | BIOSEAL | 2023-10-09 |
| 00630094192390 | Bioseal Inc. | BIOSEAL | 2023-10-09 |
| 00630094192345 | Bioseal Inc. | BIOSEAL | 2023-10-09 |
| 10888277383142 | MEDLINE RENEWAL | MEDLINE INDUSTRIES, INC. | 2023-10-09 |
| 14063107100458 | Stent Buttons | Boston Medical Products, Inc. | 2022-09-29 |
| 10888277385825 | Medline | MEDLINE INDUSTRIES, INC. | 2022-05-12 |
| 10620974002304 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001867 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 10620974002328 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 10810805000214 | "Retention Guard Suture Retention Plates - 3""" | PRESERVATION SOLUTIONS INC | 2018-12-07 |
| 10884521113343 | Bolsters | Covidien LP | 2018-08-19 |
| 10886982235299 | NA | Synthes GmbH | 2015-09-14 |
| 10705031005525 | ETHICON | ETHICON, LLC | 2015-09-01 |