Cleared Traditional

K831241 - LASER LAPARAXOPE

K831241 is an FDA 510(k) clearance for LASER LAPARAXOPE, manufactured by Eder Instrument Co, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K831241 · Eder Instrument Co, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
56d
Days
Class 2
Risk

K831241 is an FDA 510(k) clearance for the LASER LAPARAXOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Eder Instrument Co, Inc. (Walker, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 56 days - a notably fast clearance cycle.

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: 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 Eder Instrument Co, Inc. devices

FDA 510(k) Submission Details - K831241

510(k) Number K831241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date June 10, 1983
Days to Decision 56 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
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K831241.
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · Sharplan Lasers, Inc. · Apr 1988
CABOT FIBER LASER PROBE
K873115 · Cabot Medical Corp. · Jan 1988
LASER LAPAROSCOPY SET
K873598 · Cuda Products Co. · Jan 1988
KEYMED KEY LIGHT
K813133 · Keymed, Inc. · Nov 1981
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K800668 · KARL STORZ Endoscopy-America, Inc. · May 1980
LAPAROSCOPY CONSOLE MODEL VIII
K772242 · Kli · Dec 1977