# K951343: Karl Storz Semi-Rigid Micro-Endoscopes & Accessories for Endosccopic Gynecological Surgical Procedures

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Apr 11, 1996 after 384 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Feb 27, 2024 · Class II · Z-1473-2024: Inadequate reprocessing validation evidence

## Indications for use
The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.

Source page: https://510kreport.com/device/K951343
Methodology: https://510kreport.com/methodology