# K053311: Stryker Scope Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jan 27, 2006 after 60 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 1 generation back to K931895 (1993). 1 ancestor in all.
24 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931895: Endoscope Accessory, Applied Medical Resources (1993) Summary page 1.

## Most influential descendants
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own

## Recalls of this device
- Jun 21, 2010 · Not classified · Z-2622-2010: Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.

## Indications for use
The Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker Scope Warmer is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.

Source page: https://510kreport.com/device/K053311
Methodology: https://510kreport.com/methodology