Cleared Traditional

K842498 - DANIELL DBL PUNCTURE LASER LAPAROSCOPY

K842498 is the FDA 510(k) clearance for DANIELL DBL PUNCTURE LASER LAPAROSCOPY by Laser Spectrum, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K842498 · Laser Spectrum, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
91d
Days
Class 2
Risk

K842498 is an FDA 510(k) clearance for the DANIELL DBL PUNCTURE LASER LAPAROSCOPY. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Laser Spectrum, Inc. (Walker, US). The FDA issued a Cleared decision on September 25, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Laser Spectrum, Inc. devices

Submission Details

510(k) Number K842498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date September 25, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 160d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K842498.
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · Cabot Medical Corp. · May 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · Sharplan Lasers, Inc. · Apr 1988
CABOT FIBER LASER PROBE
K873115 · Cabot Medical Corp. · Jan 1988
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K800668 · KARL STORZ Endoscopy-America, Inc. · May 1980
LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS
K770378 · Richard Wolf Medical Instruments Corp. · Mar 1977
TROCAR SLEEVE SYSTEM
K770379 · Richard Wolf Medical Instruments Corp. · Mar 1977