# K935277: Karl Storz Hopkins (KSH) I Rigid Telescope, KSH II Rigid Telescope, KSH Rigid Operating Scopes Karl Storz Oval Sheath

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Sep 16, 1994 after 317 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962256: Galileo Hysteroscopes and Laparoscopes (1996), 21 descendants of its own
- K031974: Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 (2003), 20 descendants of its own
- K060899: Flexilux II Cystoscope and Hysteroscope (2007), 19 descendants of its own
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own

Source page: https://510kreport.com/device/K935277
Methodology: https://510kreport.com/methodology