Cam-Wrap
510(k) K810292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810292 | Date4 Mar 1981 | 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- Withdrawn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
- FTA
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4580
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cam-Wrap is a surgical accessory classified as a Light, Surgical, designed to secure and stabilize dressings, gauze, or other materials around a wound or surgical site. It is intended to provide a protective barrier and maintain compression, aiding in wound care and reducing the risk of contamination or displacement of dressings during the healing process.
This device is supplied as a single-use item and is intended for use in surgical and post-operative settings. It is not sterile at the time of shipment but is packaged in a manner that allows for terminal sterilization if required by the user. The Cam-Wrap is regulated under FDA 510(k) clearance (K810292) and falls under the classification of Class II medical devices. It is intended for general and plastic surgery applications and must be handled in accordance with standard medical device regulations.
Other devices from Medline Industries, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Cam-Wrap in surgical settings?
The Cam-Wrap is designed to secure and stabilize dressings, gauze, or other wound care materials around a surgical site or wound. Its main function is to provide a protective barrier while maintaining compression, which helps reduce the risk of contamination or displacement of dressings during the healing process. This makes it particularly useful in both surgical and post-operative care.
Is the Cam-Wrap intended for single-use or can it be reused?
The Cam-Wrap is explicitly labeled as a single-use item, meaning it is intended for one-time use only. While it is not sterile at the time of shipment, it is packaged in a way that allows for terminal sterilization if required by the user before use. However, reuse is not recommended or supported by the manufacturer.
What types of surgical specialties is the Cam-Wrap approved for?
The Cam-Wrap is approved for use in general and plastic surgery applications, as indicated by its regulatory submission under the advisory committee description for these specialties. It is not intended for other surgical fields unless explicitly stated otherwise.
How should the Cam-Wrap be stored before use?
The Cam-Wrap is packaged in a manner that allows for terminal sterilization if needed, but it is not sterile at the time of shipment. It should be stored according to standard medical device guidelines to maintain its integrity until ready for use. Always follow manufacturer instructions for proper storage to ensure effectiveness and safety.
What regulatory pathway was followed for the Cam-Wrap’s approval?
The Cam-Wrap was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process. It was determined to be substantially equivalent to a predicate device and falls under the classification of Class II medical devices. The clearance number is K810292, and it is regulated under FDA regulation number 878.4580.