DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)— 510(k) K062779
Substantially EquivalentNew Wave Surgical Corporation
FDA 510(k) clearance K062779 for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP), Substantially Equivalent on 2006-10-05. Applicant: New Wave Surgical Corporation. Device class: 2.
Clearance details
- Applicant
- New Wave Surgical Corporation
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K062779
K-number listed on FDA's recall record- Z-0889-2017 — Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
- Z-0890-2017 — Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062779.
Data sourced from openFDA. This site is unofficial and independent of the FDA.