Pliers, Surgical
Surgical pliers are handheld instruments used in general and plastic surgical procedures to grip, bend, or manipulate tissue, sutures, or implant components. They are classified as an FDA Class 1 device under 21 CFR 878.4800, indicating minimal risk subject only to general controls. Product code HTC falls under the General and Plastic Surgery medical specialty.
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Basic Information
- Product Code
- HTC
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Jul 02, 1987 | Substantially Equivalent | Med-Tool, Inc. |
| K864019 | NEEDLE NOSE PLIERS | Oct 30, 1986 | Substantially Equivalent | Med-Tool, Inc. |
| K861953 | PARALLEL ACTION PLIERS | Jun 06, 1986 | Substantially Equivalent | Med-Tool, Inc. |
| K854390 | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS | Nov 19, 1985 | Substantially Equivalent | Med-Tool, Inc. |
| K844600 | SLIP JOINT PLIERS | Dec 14, 1984 | Substantially Equivalent | Med-Tool, Inc. |
| K844146 | TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW | Nov 20, 1984 | Substantially Equivalent | Med-Tool, Inc. |
| K840980 | HALF ROUND FILE | Apr 25, 1984 | Substantially Equivalent | Med-Tool, Inc. |
| K840979 | SLIP JOINT PLIER | Apr 25, 1984 | Substantially Equivalent | Med-Tool, Inc. |
| K840978 | TOGGLE LOCKING PLIER | Apr 25, 1984 | Substantially Equivalent | Med-Tool, Inc. |
| K830721 | WIRE TWISTERS | Apr 12, 1983 | Substantially Equivalent | The Anspach Effort, Inc. |
FEI Numbers
This FDA classification entry is associated with 245 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 245 registration numbers. Click on an entry to view related FDA registrations.