Cleared Traditional

K812206 - LAPAROSCOPE

K812206 is an FDA 510(k) clearance for LAPAROSCOPE, manufactured by Reznik Instruments. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K812206 · Reznik Instruments · Obstetrics & Gynecology device
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Oct 1981
Decision
70d
Days
Class 2
Risk

K812206 is an FDA 510(k) clearance for the LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Reznik Instruments (Walker, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 70 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 Reznik Instruments devices

FDA 510(k) Submission Details - K812206

510(k) Number K812206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1981
Decision Date October 13, 1981
Days to Decision 70 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
90d faster than avg
Panel avg: 160d · This submission: 70d
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 K812206.
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
LAPAROSCOPE W/REMOVABLE OPTICS
K772185 · Kli · Nov 1977