Dissector, Surgical, General & Plastic Surgery
The Dissector, Surgical, General and Plastic Surgery (product code GDI) is a blunt or sharp instrument used to separate and dissect tissue planes during general or plastic surgical procedures, facilitating access to deeper anatomical structures without unnecessary damage to surrounding tissue. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GDI
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896383 | DISPOSABLE EXTERNAL CLAMPS | Dec 06, 1989 | Substantially Equivalent | Galenica Enterprises, Inc. |
| K850288 | HEPATIC PARENCHYMAL SUCTION DISSECTOR | Mar 18, 1985 | Substantially Equivalent | Beecher Medical Diagnostic Instrumentation |
| K831912 | ROUND-BEEHIVE- DISSECTORS 3/8 | Oct 31, 1983 | Substantially Equivalent | Ormed Mfg., Inc. |
| K822569 | TYMPANOPLASTY & SKIN DISSECTORS | Oct 06, 1982 | Substantially Equivalent | Kelleher Corp. |
| K803292 | FIELD SUCTION DISSECTOR | Jan 29, 1981 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K791870 | DISPOSABLE SPECIALITY SPONGES | Nov 05, 1979 | Substantially Equivalent | Carwild Corp. |
| K791703 | TEW BYPASS INSTRUMENTS & DISSECTING KIT | Oct 04, 1979 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 274 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 274 registration numbers. Click on an entry to view related FDA registrations.