KGS · Retention Device, Suture
General, Plastic Surgery · 21 CFR 878.4930 · Class 1
Overview
| Product Code | KGS |
|---|---|
| Device Name | Retention Device, Suture |
| Regulation | 21 CFR 878.4930 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030031 | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | Jan 28, 2003 | SESE |
| K020480 | RBM | Smith & Nephew, Inc. | Mar 12, 2002 | SESE |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | Feb 25, 1997 | SESE |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | Jun 30, 1995 | SESE |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | Nov 9, 1993 | SESE |
| K904435 | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | Aug 29, 1991 | SESE |
| K911225 | TRAY DOUGH | The Hygenic Corp. | Apr 17, 1991 | SESE |
| K904136 | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | Oct 2, 1990 | SESE |
| K902001 | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | May 9, 1990 | SESE |
| K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | Nov 20, 1989 | SESE |
| K893995 | DERMACARE TIE HOLDER | Dermacare | Aug 11, 1989 | SESE |
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | Feb 27, 1989 | SESE |
| K883299 | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | Aug 23, 1988 | SESE |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | Sep 16, 1987 | SESE |
| K863570 | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | Sep 29, 1986 | SESE |
| K832138 | BIOMER * PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | May 23, 1984 | SESE |
| K813581 | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | Mar 23, 1982 | SESE |
| K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | ETHICON, Inc. | Nov 20, 1981 | SESE |
| K792004 | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | Nov 5, 1979 | SESE |
| K771554 | SUTURE RETENTION CLAMP | Concept, Inc. | Sep 2, 1977 | SESE |
Top Applicants
- Acufex Microsurgical, Inc. — 4 clearances
- ETHICON, Inc. — 2 clearances
- Concept, Inc. — 2 clearances
- The Hygenic Corp. — 1 clearance
- Tek-Aid, Inc. — 1 clearance
