Slotted Soft-Tissue Instrument
FDA 510(k) K841623 · Plastafil, Inc.
510(k) numberK841623
Submission
- Device name
- Slotted Soft-Tissue Instrument
- Applicant
- Plastafil, Inc.
Mchenry, IL, US - Received
- April 19, 1984
- Decision date
- July 11, 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 |
| K843592 | Vico Micro Surgical InstrumentsHWQ · Traditional | Visitec Co. | 10/05/1984SE |
| 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 |
|---|---|---|
| K841621 | Back Radius CutterHTX · Traditional | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | 09/20/1984SE |
| K841629 | Drill BitHTW · Traditional | 08/27/1984SE |
| K841627 | MalletHWA · Traditional | 08/27/1984SE |
| K841626 | PunchHXG · Traditional | 08/27/1984SE |
| K841625 | HookGAD · Traditional | 08/27/1984SE |
| K841624 | ProbeHRX · Traditional | 08/27/1984SE |
| K841618 | Threading TubeFZX · Traditional | 08/27/1984SE |
| K841617 | Strover HookHCF · Traditional | 08/27/1984SE |
| K841628 | WireHXN · Traditional | 07/23/1984SE |
Questions and answers
When was Slotted Soft-Tissue Instrument cleared by the FDA?
Slotted Soft-Tissue Instrument (K841623) received a 510(k) decision of Substantially Equivalent on July 11, 1984, 83 days after the submission was received.
What is the product code of K841623?
The FDA product code is HWQ – Passer, a Class I (low risk) device regulated under 21 CFR 888.4540.