Vico Micro Surgical Instruments
FDA 510(k) K843592 · Visitec Co.
510(k) numberK843592
Submission
- Device name
- Vico Micro Surgical Instruments
- Applicant
- Visitec Co.
Mchenry, IL, US - Received
- September 12, 1984
- Decision date
- October 5, 1984
- 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 |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841622 | Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | Dow Corning Corp. Healthcare Industries Materials | 07/10/1981SE |
| K791960 | Roth-Kennedy PasserHWQ · Traditional | 3M Company | 10/04/1979SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Vico Micro Surgical Instruments cleared by the FDA?
Vico Micro Surgical Instruments (K843592) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 23 days after the submission was received.
What is the product code of K843592?
The FDA product code is HWQ – Passer, a Class I (low risk) device regulated under 21 CFR 888.4540.