# K920800: Integrated Endoscopy System 1000

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 30, 1992 after 130 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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.
32 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K093717: C-Mor Visualization Device (2010), 16 descendants of its own
- K141119: Camera Enabled Probe (2014), 7 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1818-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

Source page: https://510kreport.com/device/K920800
Methodology: https://510kreport.com/methodology