Hewson A.C.L. Guide Set
FDA 510(k) K872608 · Concept, Inc.
510(k) numberK872608
Submission
- Device name
- Hewson A.C.L. Guide Set
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- July 6, 1987
- Decision date
- September 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K020480 | RBMKGS · Special | Smith & Nephew, Inc. | 03/12/2002SE |
| 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 |
More from Acufex Microsurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Hewson A.C.L. Guide Set cleared by the FDA?
Hewson A.C.L. Guide Set (K872608) received a 510(k) decision of Substantially Equivalent on September 16, 1987, 72 days after the submission was received.
What is the product code of K872608?
The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.