Mr-Iii
FDA 510(k) K002261 · Smith & Nephew, Inc.
510(k) numberK002261
Submission
- Device name
- Mr-Iii
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- July 25, 2000
- Decision date
- October 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAS – Suture, Nonabsorbable, Synthetic, Polyester
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…GAS · Special | Lsi Solutions, Inc. | 11/24/2020SE |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureGAS · Special | Lsi Solutions | 11/24/2020SE |
| K091018 | Arthrex BiowireGAS · Traditional | Arthrex, Inc. | 07/30/2010SE |
| K953128 | Suture CordGAS · Traditional | Phoenix Biomedical Corp. | 02/09/1996SN |
| K923161 | Braided Polyester Suture MaterialGAS · Traditional | Mitek Surgical Products, Inc. | 12/30/1992SE |
| K913101 | Peters Cardioflon(Tm) SutureGAS · Traditional | Promedica Products, Inc. | 08/12/1992SE |
| K915089 | Mitek Quickanchor(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 02/03/1992SE |
| K915081 | Mitek Snap Pak(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 01/31/1992SE |
| K903175 | Advance Suture Nonabsorbable Dacron SutureGAS · Traditional | Advance Suture, Inc. | 07/26/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
More from Internacional Farmaceutica, S.A. DE C.V.
| 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 Mr-Iii cleared by the FDA?
Mr-Iii (K002261) received a 510(k) decision of Substantially Equivalent on October 23, 2000, 90 days after the submission was received.
What is the product code of K002261?
The FDA product code is GAS – Suture, Nonabsorbable, Synthetic, Polyester, a Class II (moderate risk) device regulated under 21 CFR 878.5000.