Automatic Multiclip Dispos. Ligating
by Davis & Geck, Inc. 510(k)
Active
510(k) K843336
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843336 | Date31 Oct 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FZP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Clip, Implantable (FDA Product Code: FZP) designed for surgical ligation. It consists of disposable, automatic clips used to occlude tissue or vessels during procedures, ensuring secure closure without the need for manual tying. The clips are intended for single-use applications in controlled surgical environments to prevent bleeding or fluid leakage.
The Automatic Multiclip Disposable Ligating is supplied as a sterile, single-use device for surgical settings. It is classified as a Class II medical device under FDA regulations (878.4300) and received FDA 510(k) clearance (K843336) in 1984 under the Substantially Equivalent (SESE) determination. Multiple clip sizes and variants are listed in the regulatory records, indicating compatibility with various surgical needs in General and Plastic Surgery. Storage and handling follow standard sterile medical device protocols.
Other devices from Davis & Geck, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Automatic Multiclip Disposable Ligating Clip used for?
This device is designed for surgical ligation, meaning it securely closes tissue or blood vessels during procedures to prevent bleeding or fluid leakage. It eliminates the need for manual tying, ensuring a reliable and consistent closure in controlled surgical environments. The clips are particularly suited for General and Plastic Surgery applications.
How is the Automatic Multiclip Disposable Ligating Clip supplied, and is it sterile?
The Automatic Multiclip Disposable Ligating Clip is supplied as a sterile, single-use device. Sterility is critical for surgical applications to minimize infection risks, and the packaging ensures the device remains uncontaminated until use. Always follow manufacturer guidelines for opening and handling to maintain sterility.
Are the Automatic Multiclip Disposable Ligating Clips reusable, or are they intended for single-use?
These clips are explicitly designed for single-use only. Single-use devices reduce the risk of cross-contamination and ensure consistent performance, as reuse could compromise sterility and structural integrity. After use, the clips should be disposed of according to medical waste protocols.
What sizes or variants of the Automatic Multiclip Disposable Ligating Clip are available?
Multiple clip sizes and variants are available, as indicated in regulatory records. These variants are designed to accommodate different surgical needs, ensuring compatibility with various tissue types and vessel sizes in General and Plastic Surgery. The exact sizes can be referenced in the product documentation or through the manufacturer.
How should the Automatic Multiclip Disposable Ligating Clip be stored?
The clips should be stored in accordance with standard sterile medical device protocols. This typically involves keeping them in their original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures sterility and maintains the device’s integrity until use.