Retainer, Surgical
The Retainer, Surgical (product code GCZ) is a surgical instrument or device used to hold tissue, organs, or structures in place or maintain their position during a surgical procedure, providing stability or protection of adjacent anatomy in general or plastic surgery. 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
- GCZ
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904536 | JAIN GRAFT ASSIST | Nov 29, 1990 | Substantially Equivalent | Jain Surgical Equipment, Inc. |
| K893870 | ADAMS BREAST IMPLANT PROTECTOR | Jul 14, 1989 | Substantially Equivalent | Adept-Med Intl., Inc. |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | Mar 19, 1987 | Substantially Equivalent | Adept-Med Intl., Inc. |
| K802806 | VISECERA RETAINER | Jan 23, 1981 | Substantially Equivalent | Adept-Med Intl., Inc. |
| K801610 | CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR | Aug 04, 1980 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.