Hook, Surgical, General & Plastic Surgery
The Hook, Surgical, General and Plastic Surgery (product code GDG) is a manually operated hooked instrument used to retract, lift, or manipulate tissue or vessels during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no 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
- GDG
- 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 |
|---|---|---|---|---|
| K900069 | MODIFIED PGL ABSORBABLE STAPLE* | Apr 16, 1990 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K891898 | SKIN HOOKS, VARIOUS TYPES | Apr 12, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K864425 | RAYLOR(TM) DISSECTING HOOK | Dec 12, 1986 | Substantially Equivalent | Cedar Surgical, Inc. |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Sep 25, 1984 | Substantially Equivalent | Brimfield Scientific Instruments |
| K841010 | SURGICAL HOOKS, VARIOUS | May 01, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K812562 | SURGICAL RETRACTOR & ELASTIC STAYS, DISP | Oct 02, 1981 | Substantially Equivalent | Humboldt Products |
| K791120 | MIDDLE EAR PICKS, HOOKS CURETTES, | Jul 10, 1979 | Substantially Equivalent | Xomed, Inc. |
| K780289 | NERVE APPROXIMATER | Jun 14, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K771190 | ABRAMSON TRACHEA HOOK & RETRACTOR | Jul 11, 1977 | Substantially Equivalent | Edward Weck, Inc. |
| K771187 | DERMAHOOK #382-805 | Jul 11, 1977 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 315 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 315 registration numbers. Click on an entry to view related FDA registrations.