Force 10, 20, 30, and 40
510(k) K905605
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905605 | Date14 Mar 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Force 10, 20, 30, and 40 are electrosurgical generators designed for use by qualified medical professionals in general and plastic surgery procedures. These devices deliver controlled electrical energy for cutting and coagulating tissue during surgical interventions.
Supplied as reusable medical equipment, the Force series generators are intended for use in clinical settings such as operating rooms. They received FDA 510(k) clearance (K905605) on March 14, 1991, and are classified under product code GEI with advisory committee review in general and plastic surgery (SU).
Other devices from Valleylab, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Force 10, 20, 30, and 40 used for?
The Force series generators deliver controlled electrical energy for cutting and coagulating tissue during surgical procedures, intended for use by qualified medical professionals in general and plastic surgery settings.
Is the Force series generator reusable or single-use?
The Force 10, 20, 30, and 40 are supplied as reusable medical equipment, designed for repeated use in clinical environments such as operating rooms after appropriate cleaning and maintenance.
How was the Force series cleared for market?
The Force 10, 20, 30, and 40 received FDA 510(k) clearance under submission K905605 on March 14, 1991, based on a determination of substantial equivalence to a predicate device.
What clinical settings are the Force generators intended for?
These devices are intended for use in clinical settings such as operating rooms, where qualified medical professionals perform general and plastic surgery procedures requiring electrosurgical cutting and coagulation.