Cleared Traditional

K010569 - KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC S...

K010569 is the FDA 510(k) clearance for KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC S... by Karl Storz Endoscopy. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K010569 · Karl Storz Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
42d
Days
Class 2
Risk

K010569 is an FDA 510(k) clearance for the KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 42 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.

View all Karl Storz Endoscopy devices

Submission Details

510(k) Number K010569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date April 09, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - GCJ Laparoscope, General & Plastic Surgery

All 705
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K010569.
LAPAROSCOPIC HAND PORT
K003871 · Applied Medical Resources Corp. · May 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc. · May 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · Smith & Nephew, Inc. · Apr 2001
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
K003790 · Davol, Inc. · Dec 2000
3D ENDOSCOPE
K002924 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · Intuitive Surgical, Inc. · Aug 2000