Surgisteel
FDA 510(k) K865038 · Sutures , Ltd.
510(k) numberK865038
Submission
- Device name
- Surgisteel
- Applicant
- Sutures , Ltd.
Ruabon, Wrexham, GB - Received
- December 24, 1986
- Decision date
- June 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair SystemGAQ · Traditional | Conextions Medical | 04/22/2022SE |
| K193209 | Wego-Stainless SteelGAQ · Traditional | Foosin Medical Supplies Inc., Ltd. | 02/19/2020SE |
| K172146 | MeristeelGAQ · Traditional | M/s. Meril Endo Surgery Private Limited. | 02/01/2018SE |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel SutureGAQ · Special | ETHICON, Inc. | 11/01/2017SE |
| K141007 | Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional | Demetech Corp. | 09/25/2014SE |
| K140127 | Ferrofibre Stainless Steel Suture with CrimpGAQ · Special | Pontis Orthopaedics, LLC | 05/28/2014SE |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated | Core Essence Orthopaedics, LLC | 12/24/2008SE |
| K082828 | Suturtek 360 Degree Sternal Closure DeviceGAQ · Special | Suturtek Incorporated | 10/14/2008SE |
| K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17GAQ · Abbreviated | Suturtek Incorporated | 02/07/2007SE |
| K042606 | Modification To:Synthes (USA) Titanium WireGAQ · Traditional | Synthes (Usa) | 05/27/2005SE |
More from Synthes (Usa)
| 510(k) | Device | Decision |
|---|---|---|
| K990432 | SurgisorbGAM · Traditional | 05/27/1999SN |
| K953609 | ProdekGAW · Traditional | 01/31/1996SN |
| K943627 | SurgisilkGAP · Traditional | 12/05/1994SN |
| K943223 | Surgidek BGAR · Traditional | 12/05/1994SN |
| K943222 | Surgidek SGAR · Traditional | 12/05/1994SN |
| K943221 | SurgibondGAT · Traditional | 12/05/1994SN |
| K943220 | SutuleneGAT · Traditional | 12/05/1994SN |
| K943218 | Chromic CatgutGAL · Traditional | 12/05/1994SN |
| K943217 | Plain CatgutGAL · Traditional | 12/05/1994SN |
| K943216 | SurgidekGAR · Traditional | 12/05/1994SN |
Questions and answers
When was Surgisteel cleared by the FDA?
Surgisteel (K865038) received a 510(k) decision of Substantially Equivalent on June 30, 1987, 188 days after the submission was received.
What is the product code of K865038?
The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.