Cleared Traditional

K062779 - DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP)

Also marketed or referenced as:
DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

K062779 is an FDA 510(k) clearance for DEFOGGING HEATED ENDOSCOPE LENS PROTECT..., manufactured by New Wave Surgical Corporation. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K062779 · New Wave Surgical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
17d
Days
Class 2
Risk

K062779 is an FDA 510(k) clearance for the DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by New Wave Surgical Corporation (Great Neck, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062779

510(k) Number K062779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date October 05, 2006
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K062779.
TRUEHD (1080P) DIGITAL CAMERA SYSTEM
K063457 · Conmed Linvatec · Dec 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · Medtronic Vascular · Oct 2006
BASX BLADELESS TROCAR
K062209 · Ethicon Endo-Surgery, LLC · Oct 2006
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
K060182 · Australian Surgical Devices · Sep 2006
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
K062326 · United States Surgical, A Division of Tyco Healthc · Sep 2006
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
K061555 · Anchor Products Co. · Aug 2006

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K062779 · DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP)
Download PDF FDA Summary New Wave Surgical Cor…