Opportunity Inc. Laceration Tray
510(k) K971089
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK971089 | Date16 Sep 1997 | 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- Withdrawn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
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SN
Overview
AI-generated summary, 20 Sep 2026
The Opportunity Inc. Laceration Tray is a Drape, Surgical (product code KKX) designed for use in laceration repair procedures. It is a pre-assembled kit containing medical instruments and supplies intended to assist in wound closure and preparation. The device falls under the classification of Class II – Special Controls, as defined by regulatory standards. Its primary function is to provide organized access to essential tools and materials during surgical or procedural interventions for lacerations.
This device is supplied as a single-use item and is intended for use in clinical settings by licensed professionals or medical personnel. It was granted FDA 510K clearance under the traditional review pathway, with a decision issued on September 16, 1997. The tray is intended for general hospital use and adheres to standard sterility and handling protocols for surgical drapes. No additional regulatory markings beyond the FDA clearance are referenced in the specifications.
Other devices from Opportunity, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of medical procedures is the Laceration Tray specifically designed to assist with?
The Laceration Tray is designed to assist in laceration repair procedures, providing organized access to instruments and supplies needed for wound closure. It is intended for use in surgical or procedural settings where lacerations require careful preparation and closure, such as those seen in general surgery or plastic surgery contexts.
Is the Laceration Tray reusable, or is it meant for single-use only?
The Laceration Tray is explicitly labeled as a single-use item, meaning it is intended for one-time use in a clinical setting before disposal. This aligns with standard sterility and infection control protocols for surgical drapes and kits.
What does the FDA’s clearance decision for this device mean in practical terms for clinicians?
The FDA granted the Laceration Tray 510K clearance under the traditional review pathway, determining it is *substantially equivalent* for some indications to a legally marketed device. This means clinicians can rely on it as a validated option for laceration repair, though it is not intended for all wound types—only those explicitly covered by its classification (product code KKX). The decision reflects its compliance with safety and performance standards for surgical drapes.
How should the Laceration Tray be stored to maintain its sterility and usability?
Since it is a sterile, single-use surgical drape kit, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility until first use, so avoid opening or handling the contents prematurely. Follow manufacturer guidelines for expiration dates if applicable.
Are there different sizes or models of the Laceration Tray, or is it a one-size-fits-all solution?
The provided data does not specify multiple sizes or models for the Laceration Tray. It is described as a pre-assembled kit for general laceration repair, implying a standardized configuration. Clinicians should confirm compatibility with their specific procedural needs or consult the manufacturer for variations if available.