Cleared Traditional

K053412 - FLEXISCOPE

K053412 is an FDA 510(k) clearance for FLEXISCOPE, manufactured by Schoelly Imaging, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWF cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K053412 · Schoelly Imaging, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
78d
Days
Class 1
Risk

K053412 is an FDA 510(k) clearance for the FLEXISCOPE, MODELS 50MH AND 50 MHC. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by Schoelly Imaging, Inc. (Ayer, US). The FDA issued a Cleared decision on February 23, 2006 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - 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.

View all Schoelly Imaging, Inc. devices

FDA 510(k) Submission Details - K053412

510(k) Number K053412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2005
Decision Date February 23, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

FWF Device Classification - Class 1, General Controls

Product Code FWF Camera, Television, Endoscopic, Without Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FWF Camera, Television, Endoscopic, Without Audio

All 7
Devices cleared under the same product code (FWF) and FDA review panel - the closest regulatory comparables to K053412.
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
K982965 · Richard Wolf Medical Instruments Corp. · Nov 1998
FUJINON VIDEO LAPAROSCOPE, MODIFIED
K930297 · Fujinon, Inc. · Mar 1994
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K930053 · Medical Devices, Inc. · May 1993
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
K881014 · KARL STORZ Endoscopy-America, Inc. · Apr 1988
RGB CAMERA SYSTEM
K872661 · Aspen Laboratories, Inc. · Jul 1987
VIDEO CAMERA SYSTEM
K863598 · American Edwards Laboratories · Oct 1986