# K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)

- Pathway: 510(k) (Traditional)
- Applicant: New Wave Surgical Corporation
- Decided: Oct 5, 2006 after 17 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904871 (1991). 15 ancestors in all.
23 later devices descend from it; 5 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993604: Endoscopic Anti Fog Device, Mectra Labs, Inc. (2000) Summary page 1.
- K022826: Clear-IT Anti-Fog, Model PS003, Preservation Solutions, Inc. (2002) Summary page 1.
- K974454: Clearfield Anti-Fog Sterile Wipe, Product Number 300-004, Tucson Medical Corp. (1997) Summary page 1.
- K931895: Endoscope Accessory, Applied Medical Resources (1993) Summary page 1.
- K053311: Stryker Scope Warmer, Stryker Endoscopy (2006) Summary page 1.
- K982465: Deroyal Industries, Inc. Defogger, Deroyal Industries, Inc. (1998) Summary page 1.
- K051979: Ors Model 6000 Endoscope Holder, O.R. Solutions, Inc. (2005) Summary page 1.
- K023506: Surgical Medical Device Cautery, Modern Medical Equipment Mfg., Ltd. (2004) Summary page 1.
- K052797: Lapevac, Filtration Device for the Periotoneum, Medtek Devices, Inc. (2006) Summary page 2.
- K992126: Circon Surgiflex Wave Tsunami Suction-Irrigation System, Circon Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K192891: Laparoscope Lens Shield Device (LENS) (2019), 4 descendants of its own

## Recalls of this device
- Oct 4, 2016 · Class II · Z-0889-2017: Product sterility is compromised due to breach of the sterile barrier
- Oct 4, 2016 · Class II · Z-0890-2017: Product sterility is compromised due to breach of the sterile barrier

## Indications for use
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Source page: https://510kreport.com/device/K062779
Methodology: https://510kreport.com/methodology