FDA product code KGS: Retention Device, Suture
KGS is the FDA product code for retention device, suture. It is a Class I device, regulated under 21 CFR 878.4930 and reviewed by the General and Plastic Surgery panel. FDA has cleared 20 510(k) submissions under KGS, from 15 different applicants. The average 510(k) review took 103 days (median 38). FDA has posted 2 recalls for KGS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retention Device, Suture |
| Device class | Class I |
| Regulation | 21 CFR 878.4930 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KGS clearance
Top KGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acufex Microsurgical, Inc. | 4 | 1995-06-30 |
| Concept, Inc. | 2 | 1987-09-16 |
| ETHICON, Inc. | 2 | 1984-05-23 |
| Accu-Speed, Incorporated | 1 | 2003-01-28 |
| Smith & Nephew, Inc. | 1 | 2002-03-12 |
10 more applicants have KGS clearances. See the full list in Caduvo.
Most recent KGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030031 | Accu-Speed, Incorporated | SOFT TISSUE ANCHORING WASHERS | 2003-01-28 | 25 |
| K020480 | Smith & Nephew, Inc. | RBM | 2002-03-12 | 27 |
| K964935 | Smith & Nephew Endoscopy, Inc. | SUTURE LOCK | 1997-02-25 | 77 |
| K941740 | Acufex Microsurgical, Inc. | ACUFEX ROTATOR CUFF FIXATION BUTTON | 1995-06-30 | 449 |
| K930675 | Mitek Surgical Products, Inc. | MITEK CONE WASHER | 1993-11-09 | 273 |
Recalls for KGS devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-16.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code KGS?
KGS is the FDA product code for retention device, suture. It is a Class I device, regulated under 21 CFR 878.4930 and reviewed by the General and Plastic Surgery panel.
What device class is KGS?
Class I, regulation 21 CFR 878.4930. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGS?
Across 20 cleared submissions the average was 103 days from receipt to decision (median 38).
Which companies have the most KGS clearances?
Acufex Microsurgical, Inc. (4); Concept, Inc. (2); ETHICON, Inc. (2); Accu-Speed, Incorporated (1); Smith & Nephew, Inc. (1).
Have KGS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KGS
- Run a recall and safety report across every KGS manufacturer
- Watch product code KGS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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