Applier, Hemostatic Clip
The Hemostatic Clip Applier is a surgical instrument used to deploy small metal or polymer clips onto blood vessels or tissue to achieve hemostasis during general and plastic surgery procedures, replacing the need for suture ligation in many applications. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBT under regulation 21 CFR 878.4800 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HBT
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924929 | REFLEX(R) ECA | Jul 21, 1993 | Substantially Equivalent | Richard-Allan Medical |
| K896262 | TITANIUM LIGATING CLIPS | Jan 02, 1990 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | Jul 30, 1986 | Substantially Equivalent | Downs Surgical , Ltd. |
| K800318 | DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI | Mar 10, 1980 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.