Debridement Tray, Incision and Drainage Tray
510(k) K963715
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963715 | Date27 Nov 1996 | 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- Withdrawn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
- LRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a surgical tray designed for debridement, incision management, and drainage procedures. It includes a plastic wound protector for securing around surgical incisions or within wounds to cover exposed edges, alongside a latex drape with a self-retaining finger cot to facilitate repeated surgeon access. The tray supports wound care by providing a sterile barrier and access point for surgical intervention. Its components are intended to minimize contamination and aid in maintaining a clean surgical field during procedures.
The debridement tray is supplied as a reusable medical device and is intended for use in surgical settings, including operating rooms and procedural suites. It is classified under product code LRO (General Surgery Tray) and has received FDA 510(k) clearance (K963715) as substantially equivalent to a predicate device. The tray’s components, including the latex drape, must be inspected and maintained per manufacturer guidelines to ensure sterility and functionality. No specific MRI safety or single-use designation is noted in the regulatory data.
Other devices from Grand Medical Products
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of the Debridement Tray, Incision and Drainage Tray?
This surgical tray is designed for debridement, incision management, and drainage procedures. It includes a plastic wound protector and latex drape with finger cot to maintain a sterile field while providing surgeon access during wound care interventions.
How is the Debridement Tray supplied and what is its intended use setting?
The tray is supplied as a reusable medical device intended for use in surgical settings including operating rooms and procedural suites. Components must be inspected and maintained per manufacturer guidelines to ensure sterility and functionality.
What regulatory clearance has this device received?
The Debridement Tray has received FDA 510(k) clearance (K963715) as substantially equivalent to a predicate device. It is classified under product code LRO (General Surgery Tray) and was reviewed by the General and Plastic Surgery advisory committee.
Are there specific MRI safety considerations or single-use designations for this tray?
No specific MRI safety designation or single-use designation is noted in the regulatory data for this device. It is supplied as a reusable medical device that requires proper maintenance to ensure sterility and functionality.