# K041321: Veroscope Optical Veress Cannula & Dilation Tube System

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jul 9, 2004 after 52 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940232 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962799: Miniature Laparoscope Set (Mini Lap), Richard Wolf GmbH (1996) Summary page 1.
- K971420: Microendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress Cannula (8755.211,212), Richard Wolf Medical Instruments Corp. (1997) Summary page 1.
- K003417: Mini Fiber Endoscopes; Outer Sheaths; Veress Cannulas; Veress Cannulas with Outer Sheaths, Set, Richard Wolf Medical Instruments Corp. (2001) Summary page 1.
- K942201: Laparoscopy Dilation System, Richard Wolf Medical Instruments Corp. (1994) Summary page 1.
- K983925: Endopath Ultra Veress Needle, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K012539: Verastep, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- (no number) Optical VERESS Pneumoperitoneum Needle: named in the summary without a submission number

## Most influential descendants
- K062097: Veress Cannula and Modular Veress Cannula (2006), 0 descendants of its own

## Indications for use
The VEROSCOPE is used percutaneously for penetrating the abdominal cavity under endoscopic control to safely reach a defined body region. It therefore also serves to create a pneumoperitoneum under visual control in the abdomen. The Dilation Tube System and standard Dilation System is used for dilating surgically created passages in body cavities. The Veroscope and dilation tube systems are used for diagnosis and therapy in conjunction with endoscopic accessories in various disciplines such as surgery, gynecology and urology.

Source page: https://510kreport.com/device/K041321
Methodology: https://510kreport.com/methodology