RBM
FDA 510(k) K020480 · Smith & Nephew, Inc.
510(k) numberK020480
Submission
- Device name
- RBM
- Applicant
- Smith & Nephew, Inc.
Mansfield, MA, US - Received
- February 13, 2002
- Decision date
- March 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGS – Retention Device, Suture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4930
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030031 | Soft Tissue Anchoring WashersKGS · Traditional | Accu-Speed, Incorporated | 01/28/2003SE |
| K964935 | Suture LockKGS · Traditional | Smith & Nephew Endoscopy, Inc. | 02/25/1997SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | Acufex Microsurgical, Inc. | 06/30/1995SE |
| K930675 | Mitek Cone WasherKGS · Traditional | Mitek Surgical Products, Inc. | 11/09/1993SE |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | Aesculap, Inc. | 08/29/1991SE |
| K911225 | Tray DoughKGS · Traditional | The Hygenic Corp. | 04/17/1991SE |
| K904136 | Suture Tension Adjustment ReelKGS · Traditional | Surgical Systems, Inc. | 10/02/1990SE |
| K902001 | Surgical Retention BarKGS · Traditional | Acufex Microsurgical, Inc. | 05/09/1990SE |
| K896310 | Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional | Acufex Microsurgical, Inc. | 11/20/1989SE |
| K893995 | Dermacare Tie HolderKGS · Traditional | Dermacare | 08/11/1989SE |
More from Dermacare
| 510(k) | Device | Decision |
|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | 09/08/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | 07/09/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was RBM cleared by the FDA?
RBM (K020480) received a 510(k) decision of Substantially Equivalent on March 12, 2002, 27 days after the submission was received.
What is the product code of K020480?
The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.