Veroscope Optical Veress Cannula & Dilation Tube System
by Richard Wolf Medical Instruments Corp.
510(k) K041321
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041321 | Date9 Jul 2004 | 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- Withdrawn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
- HET
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1720
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Veroscope Optical Veress Cannula & Dilation Tube System is a laparoscope and gynecologic accessory system used for diagnosis and therapy in conjunction with endoscopic accessories. It is designed for use in surgical procedures involving body cavities, particularly in the disciplines of surgery, gynecology, and urology.
The system is supplied as a reusable device and is used for dilating surgically created passages in body cavities. It received FDA 510(k) clearance (K041321) as a Class II device with product code HET, determined to be substantially equivalent to a legally marketed predicate device. It is intended for use in clinical settings under standard conditions of use, with no indications of sterility, single-use status, MRI safety, or specific storage conditions provided in the data.
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Questions
AI-generated answers, 22 Sep 2026
What is the Veroscope Optical Veress Cannula & Dilation Tube System used for?
It is used for diagnosis and therapy in conjunction with endoscopic accessories, specifically to dilate surgically created passages in body cavities during procedures in surgery, gynecology, and urology.
Is the Veroscope Optical Veress Cannula & Dilation Tube System reusable or single-use?
The system is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and reprocessing in accordance with the manufacturer's instructions.
What regulatory pathway was used for the Veroscope Optical Veress Cannula & Dilation Tube System?
It received FDA 510(k) clearance (K041321) as a Class II device, determined to be substantially equivalent to a legally marketed predicate device under the traditional review pathway.