# K973737: Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM, Dilatation Sleeve and Guide Rod 2 MM to 3.M

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Dec 12, 1997 after 73 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: 1 generation back to K932441 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932441: Series 8920 Trocar System, Richard Wolf Medical Instruments Corp. (1994) Summary page 1.
- K942201: Laparoscopy Dilation System, Richard Wolf Medical Instruments Corp. (1994) Summary page 1.
- (no number) Trocar sleeve with trocar: named in the summary without a submission number
- (no number) Trocars and thread sleeve: named in the summary without a submission number
- (no number) Trocars/cannulas systems: named in the summary without a submission number

## Indications for use
The trocar sleeves and trocars serve to gain access to body cavities. The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters. For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists. There are currently no known contraindications relating directly to the product. The physician should decide whether or not the planned application can be performed based on the of the patient’s general condition. The trocar sleeves and trocars are used in with insufflators, reducing adapters, reducing sleeves, extraction sleeves, dilation sleeves, guide rods, threaded fixation sleeves, sliding cones and, endoscopes, as well as endoscopic accessories (e.g. forceps, electrodes).

Source page: https://510kreport.com/device/K973737
Methodology: https://510kreport.com/methodology