Adjustable Wrenches
FDA 510(k) K874359 · Med-Tool, Inc.
510(k) numberK874359
Submission
- Device name
- Adjustable Wrenches
- Applicant
- Med-Tool, Inc.
St. Louis, MO, US - Received
- October 23, 1987
- Decision date
- November 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXC – Wrench
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180092 | IntellitorqHXC · Traditional | Gauthier Biomedical, Inc. | 03/08/2018SE |
| K874358 | Combination WrenchesHXC · Traditional | Med-Tool, Inc. | 11/23/1987SE |
| K870053 | Torquedriver WrenchHXC · Traditional | Jerome Medical | 03/11/1987SE |
| K813067 | Spinal WrenchHXC · Traditional | Twin City Surgical, Inc. | 11/24/1981SE |
| K791073 | WrenchHXC · Traditional | Truth, Inc. | 06/20/1979SE |
More from Truth, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874358 | Combination WrenchesHXC · Traditional | 11/23/1987SE |
| K874357 | Tapered PunchLRY · Traditional | 11/23/1987SE |
| K874356 | Pin PunchLRY · Traditional | 11/23/1987SE |
| K872388 | Nail SetLRY · Traditional | 07/23/1987SE |
| K872387 | Standard Screw DriverLRZ · Traditional | 07/16/1987SE |
| K872385 | Vice or Bench ViceLSA · Traditional | 07/16/1987SE |
| K872389 | Precision Screw Driver SetHXX · Traditional | 07/15/1987SE |
| K872386 | C ClampHXD · Traditional | 07/02/1987SE |
| K872384 | Side Cutting Parallel Action PliersHTC · Traditional | 07/02/1987SE |
| K864020 | Ice Pick · Traditional | 10/30/1986SE |
Questions and answers
When was Adjustable Wrenches cleared by the FDA?
Adjustable Wrenches (K874359) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 31 days after the submission was received.
What is the product code of K874359?
The FDA product code is HXC – Wrench, a Class I (low risk) device regulated under 21 CFR 888.4540.