Adjustable Fork Retractor
FDA 510(k) K833604 · Microtek Medical, Inc.
510(k) numberK833604
Submission
- Device name
- Adjustable Fork Retractor
- Applicant
- Microtek Medical, Inc.
Mchenry, IL, US - Received
- October 12, 1983
- Decision date
- January 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAL – Retractor, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870758 | Small Mastoid RetractorKAL · Traditional | Treace Medical, Inc. | 03/04/1987SE |
| K772392 | Allport Mastoid RetractorsKAL · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772381 | Ring Handle & RetractorsKAL · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K760851 | Converse Altar RetractorKAL · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 03/10/1977SE |
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| K110358 | Venodyne V810JOW · Traditional | 05/05/2011SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
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| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K022903 | ChillbusterDWJ · Traditional | 11/27/2002SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
| K001802 | Venodyne DVT Advantage Model 610JOW · Traditional | 01/09/2001SE |
Questions and answers
When was Adjustable Fork Retractor cleared by the FDA?
Adjustable Fork Retractor (K833604) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 83 days after the submission was received.
What is the product code of K833604?
The FDA product code is KAL – Retractor, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.