JJ Skinner Carekits Minor Surgical Procedure Tray
by J.J. Skinner, Inc. 510(k)
Active
510(k) K961683
Overview
The JJ Skinner Carekits Minor Surgical Procedure Tray is a sterile, single-use surgical tray designed for minor surgical procedures. Classified under product code LRO as a general surgery tray, it is intended for use in outpatient settings where procedures are performed under topical anesthesia. The tray is intended to support a range of minor surgical interventions requiring basic surgical instruments and supplies.
This tray is supplied sterile and intended for single-use only, adhering to standard surgical tray protocols. It is not MRI-compatible and must be stored in a clean, dry environment prior to use. The device received FDA 510(k) clearance under the classification of General, Plastic Surgery, with a decision date of May 10, 1996, and is regulated under 878.4370. No additional regulatory status beyond the stated clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961683 | Date10 May 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- LRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from J.J. Skinner, Inc.
Questions
What types of minor surgical procedures is this tray designed to support in an outpatient setting?
This tray is intended for minor surgical procedures performed under topical anesthesia in outpatient settings. It provides basic surgical instruments and supplies to support a range of interventions requiring standard surgical tools, such as excisions, biopsies, or minor skin repairs. The design aligns with general surgery protocols (product code LRO) and is not specialized for specific procedures beyond what basic surgical trays typically accommodate.
Is this tray reusable, or is it meant for single-use only? How should it be handled to maintain sterility?
The tray is sterile and intended for single-use only, following standard surgical tray protocols. To preserve sterility before use, it must be stored in a clean, dry environment away from contamination. Opening or handling the tray prior to the procedure could compromise its sterile status, so it should remain unopened until immediately before use.
Can this tray be used in an MRI scanner, or are there any compatibility concerns?
No, this tray is not MRI-compatible. It should never be placed in an MRI environment, as the materials or components could interfere with imaging or pose safety risks. Always verify the procedure room’s equipment before use to ensure compatibility.
What regulatory pathway was followed for FDA clearance, and what does that mean for its use?
The tray received FDA 510(k) clearance under the classification of General, Plastic Surgery (product code LRO) via a traditional review process, determined to be substantially equivalent to a predicate device. This clearance confirms it meets FDA safety and effectiveness standards for minor surgical procedures under topical anesthesia in outpatient settings, but it does not imply approval for any specific clinical indication beyond its labeled use.