Cleared Traditional

CO2 LAPAROSCOPE (K841668) - FDA 510(k) Clearance

K841668 · Laser Spectrum, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
-
Days
-
Risk

K841668 is an FDA 510(k) clearance for the CO2 LAPAROSCOPE.

Submitted by Laser Spectrum, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Laser Spectrum, Inc. devices

Submission Details

510(k) Number K841668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 23, 1984
Decision Date April 23, 1984
Days to Decision -
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -