Davol Laparoscopic Instruments (Gen Surg Reusable)
FDA 510(k)Class II (US FDA 510(k))
by Davol Inc.
Identifiers
- 510(k) Number
- K914910 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Davol Laparoscopic Instruments (Gen Surg Reusable) are reusable surgical instruments designed for use in laparoscopic procedures. These instruments are part of the electrosurgical, cutting and coagulation accessories category and are intended for general and plastic surgery applications.
The device is reusable and manufactured by Davol Inc. It received FDA 510(k) clearance with number K914910 on January 6, 1992, and was determined to be substantially equivalent. The product code is GEI, and it is regulated under classification 878.4400.
Frequently asked questions
What are Davol Laparoscopic Instruments used for?
Davol Laparoscopic Instruments (Gen Surg Reusable) are designed for use in laparoscopic procedures, specifically for general and plastic surgery applications. They fall under the electrosurgical, cutting and coagulation accessories category.
Are these instruments reusable or single-use?
These instruments are reusable, as indicated in their name and description. They are designed for multiple uses in laparoscopic surgical procedures, though proper sterilization and maintenance protocols should be followed between uses.
What is the regulatory status of these instruments?
The instruments received FDA 510(k) clearance with number K914910 on January 6, 1992, and were determined to be substantially equivalent. They are regulated under product code GEI and classification 878.4400.
Who is the manufacturer of these laparoscopic instruments?
Davol Laparoscopic Instruments (Gen Surg Reusable) are manufactured by Davol Inc., located in Cranston, Rhode Island. The company received clearance for these instruments under their name.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Davol Laparoscopic Instruments (Gen Surg Reusable), DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)… - FDA.report, Davol Laparoscopic Instruments (Gen Surg Reusable) - Beudamed, PDF K914910 - Davol Laparoscopic Instruments (Gen Surg Reusable), Davol, Inc. — 50 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914910 | Class II | Active |
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Manufacturer
- Manufacturer
- Davol Inc.
- FDA Applicant
- Davol, Inc.
Sources (1)
- FDA 510(k) K914910 24 fields · synced Sep 24, 2026