Clip, Hemostatic
The hemostatic clip is a general and plastic surgery implant used during surgical procedures to occlude small blood vessels or tissue structures to achieve hemostasis, and may remain permanently implanted at the surgical site. It is classified as FDA Class II under 21 CFR 878.4300 within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. The product code is MCH and it carries an implant flag. Full GMP quality system requirements apply.
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Basic Information
- Product Code
- MCH
- Device Class
- FDA class 2
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040148 | RESOLUTION HEMOSTASIS CLIPPING DEVICE | Apr 22, 2004 | Substantially Equivalent | Boston Scientific Corp |
| K972745 | TITANIUM HEMOSTATIC CLIP | Oct 21, 1997 | Substantially Equivalent | Eisner USA, Inc. |
| K896998 | ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) | Jun 01, 1990 | Substantially Equivalent | S.P.K. Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.