Straith Drain Inserter
FDA 510(k) K840835 · Surgical Technology Laboratories, Inc.
510(k) numberK840835
Submission
- Device name
- Straith Drain Inserter
- Applicant
- Surgical Technology Laboratories, Inc.
Mchenry, IL, US - Received
- February 24, 1984
- Decision date
- April 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZX – Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914715 | Paralleling GuidesFZX · Traditional | Implant Corp. of America | 02/16/1994SE |
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K842698 | British Spinal Fusion SetFZX · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841297 | Techmedica Drill GuideFZX · Traditional | Techmedica, Inc. | 04/25/1984SE |
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| K983756 | Surgiform Anatomical MalarLZK · Special | 11/20/1998SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | 11/20/1998SE |
| K983754 | Standard ChinFWP · Special | 11/20/1998SE |
| K964443 | Surgiform Anatomical MalarLZK · Traditional | 12/20/1996SE |
| K831078 | Straith Oral AirwayCAE · Traditional | 06/24/1983SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | 06/17/1980SE |
| K801072 | Straith Nasal SplintFYI · Traditional | 06/17/1980SE |
| K801075 | Straith Chisel ForcepsGEN · Traditional | 05/20/1980SE |
Questions and answers
When was Straith Drain Inserter cleared by the FDA?
Straith Drain Inserter (K840835) received a 510(k) decision of Substantially Equivalent on April 23, 1984, 59 days after the submission was received.
What is the product code of K840835?
The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.