Applier, Surgical, Clip
The Applier, Surgical, Clip (product code GDO) is a manually operated instrument used to deploy surgical clips onto tissue, vessels, or structures during general or plastic surgery procedures, providing a mechanism for ligation or occlusion without suturing. It is classified as FDA Class 1, posing minimal risk, 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
- GDO
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Apr 20, 1993 | Substantially Equivalent | Unisurge, Inc. |
| K890941 | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP | Apr 07, 1989 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K890159 | TOWEL CLIPS | Feb 03, 1989 | Substantially Equivalent | Dhason Brothers, Inc. |
| K890233 | SUTURE CLIP APPLIER/REMOVER | Jan 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K820837 | DISPOSABLE MULTIPLE LIGATING CLIP | May 28, 1982 | Substantially Equivalent | ETHICON, Inc. |
| K812291 | ETHICON MULTIPLE LIGATING CLIP APPLIER | Sep 11, 1981 | Substantially Equivalent | ETHICON, Inc. |
| K792378 | HEMOSPENSER CARTRIDGE CAT. NO. 523500- | Dec 06, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K791845 | BAYONET HEIFETZ CLIP APPLIERS | Oct 17, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K790855 | SURGICAL DRAPE CLIP #201 | Aug 03, 1979 | Substantially Equivalent | C. Intl. |
| K791157 | 360 HEMOCLIP APPLIERS | Jun 27, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K790990 | REYNOLDS DOUBLE HEMOCLIP APPLIERS | Jun 05, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K772286 | FORCEPS, SUTURE, AUTO | Dec 20, 1977 | Substantially Equivalent | Hartmann Group, Inc. |
| K771412 | LIGACLIP MULTIPLE CLIP APPLIER | Nov 28, 1977 | Substantially Equivalent | ETHICON, Inc. |
| K771640 | SUTURE CLIP REMOVER | Sep 30, 1977 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
FEI Numbers
This FDA classification entry is associated with 151 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 151 registration numbers. Click on an entry to view related FDA registrations.