Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4930](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4930) → KGS — Retention Device, Suture # KGS · Retention Device, Suture _General, Plastic Surgery · 21 CFR 878.4930 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS ## Overview - **Product Code:** KGS - **Device Name:** Retention Device, Suture - **Regulation:** [21 CFR 878.4930](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4930) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K030031.md) | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | Jan 28, 2003 | SESE | | [K020480](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K020480.md) | RBM | Smith & Nephew, Inc. | Mar 12, 2002 | SESE | | [K964935](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K964935.md) | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | Feb 25, 1997 | SESE | | [K941740](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K941740.md) | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | Jun 30, 1995 | SESE | | [K930675](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K930675.md) | MITEK CONE WASHER | Mitek Surgical Products, Inc. | Nov 9, 1993 | SESE | | [K904435](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K904435.md) | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | Aug 29, 1991 | SESE | | [K911225](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K911225.md) | TRAY DOUGH | The Hygenic Corp. | Apr 17, 1991 | SESE | | [K904136](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K904136.md) | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | Oct 2, 1990 | SESE | | [K902001](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K902001.md) | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | May 9, 1990 | SESE | | [K896310](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K896310.md) | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | Nov 20, 1989 | SESE | | [K893995](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K893995.md) | DERMACARE TIE HOLDER | Dermacare | Aug 11, 1989 | SESE | | [K884565](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K884565.md) | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | Feb 27, 1989 | SESE | | [K883299](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K883299.md) | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | Aug 23, 1988 | SESE | | [K872608](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K872608.md) | HEWSON A.C.L. GUIDE SET | Concept, Inc. | Sep 16, 1987 | SESE | | [K863570](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K863570.md) | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | Sep 29, 1986 | SESE | | [K832138](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K832138.md) | BIOMER * PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | May 23, 1984 | SESE | | [K813581](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K813581.md) | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | Mar 23, 1982 | SESE | | [K812819](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K812819.md) | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | ETHICON, Inc. | Nov 20, 1981 | SESE | | [K792004](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K792004.md) | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | Nov 5, 1979 | SESE | | [K771554](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K771554.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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