Silastic Tendon Passer H.P.
FDA 510(k) K811679 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK811679
Submission
- Device name
- Silastic Tendon Passer H.P.
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Walker, MI, US - Received
- June 15, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWQ – Passer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970360 | Mitek Suture RetrograderHWQ · Traditional | Mitek Products | 03/10/1997SE |
| K923381 | Soft Tissue ExpanderHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K920621 | Acufex Passing Pins and Surgical WireHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K885311 | Meniscus Mender II LoopHWQ · Traditional | Instrument Makar, Inc. | 02/09/1989SE |
| K843592 | Vico Micro Surgical InstrumentsHWQ · Traditional | Visitec Co. | 10/05/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841622 | Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K791960 | Roth-Kennedy PasserHWQ · Traditional | 3M Company | 10/04/1979SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K853186 | Silastic Inflatable Bone Plug H.P.LZN · Traditional | 09/24/1985SE |
| K844637 | Whiteside Acrylic Cement Spacer SleeveLTC · Traditional | 06/19/1985SE |
| K850255 | Dow Corning Wright Titanium Wrist Joint Grommet · Traditional | 05/01/1985SE |
| K843995 | Tf-Ii Hip ProsthesisKWL · Traditional | 04/23/1985SE |
| K842559 | Whiteside Ortholoc Total Hip FemoralKWL · Traditional | 12/20/1984SE |
| K840357 | Ssa Hip ProsthesisJDI · Traditional | 02/17/1984SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K801175 | Silastic II Mammary Implant · Traditional | 12/18/1980SE |
Questions and answers
When was Silastic Tendon Passer H.P. cleared by the FDA?
Silastic Tendon Passer H.P. (K811679) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 25 days after the submission was received.
What is the product code of K811679?
The FDA product code is HWQ – Passer, a Class I (low risk) device regulated under 21 CFR 888.4540.