# K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Mar 9, 2015 after 45 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K770378 (1977). 13 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060899: Flexilux II Cystoscope and Hysteroscope, Schoelly Imaging, Inc. (2007) Summary page 4.
- K040390: Stryker Urology and Gynecology Hardware System, Stryker Endoscopy (2004) Summary page 5.

## Most influential descendants
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own
- K190639: Endosee System (2019), 3 descendants of its own
- K251652: Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (2025), 1 descendant of its own

## Recalls of this device
- Jun 23, 2023 · Class II · Z-2364-2023: There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can

## Indications for use
The Schoelly Cystoscopes/Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Source page: https://510kreport.com/device/K150158
Methodology: https://510kreport.com/methodology