Monoscopy Brand Endobag
by Dexide, Inc. 510(k)
Active
510(k) K913762
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913762 | Date28 Oct 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Monoscopy(Tm) Brand, Endobag
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Monoscopy Brand Endobag is a surgical retrieval bag designed for the collection and containment of tissue or foreign bodies during endoscopic or laparoscopic procedures. It is classified under the product code GCJ, intended for use in gastroenterology and urology applications, where precise retrieval of specimens is critical to maintaining procedural sterility and minimizing contamination risks.
This device is supplied as a single-use, sterile item and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is regulated under FDA 510(k) clearance (K913762) and must comply with applicable standards for surgical retrieval bags, including sterility validation and material compatibility with biological tissues. No additional regulatory markings beyond the FDA clearance are referenced in the device specifications.
Other devices from Dexide, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Monoscopy Endobag used for?
The Monoscopy Endobag is designed specifically for collecting and containing tissue or foreign bodies during endoscopic or laparoscopic procedures. Its primary purpose is to ensure procedural sterility and minimize contamination risks, which is critical in gastroenterology and urology applications where precise retrieval of specimens is essential.
Is the Monoscopy Endobag single-use or reusable?
The Monoscopy Endobag is supplied as a single-use item. This design choice ensures sterility and reduces the risk of cross-contamination between procedures, adhering to best practices for surgical retrieval devices.
How is the Monoscopy Endobag sterilized?
The Monoscopy Endobag is provided in a sterile package, validated for sterility before use. This ensures that the device meets regulatory standards for surgical retrieval bags, including sterility validation, and is ready for immediate use in controlled clinical settings like operating rooms or endoscopy suites.
What are the key applications for this retrieval bag?
The Monoscopy Endobag is intended for use in gastroenterology and urology procedures where precise retrieval of specimens is necessary. Its design supports controlled clinical environments, such as endoscopic or laparoscopic surgeries, to maintain procedural integrity and reduce contamination risks.
How should the Monoscopy Endobag be stored?
The Monoscopy Endobag should be stored in its original, sealed packaging until ready for use. Proper storage ensures the device remains sterile and intact, adhering to manufacturer guidelines and regulatory requirements for single-use surgical items.