Cleared Traditional

K791182 - ACMI RIGI-FLEX NEPHORSCOPE

K791182 is the FDA 510(k) clearance for ACMI RIGI-FLEX NEPHORSCOPE by American Cystocope Makers, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K791182 · American Cystocope Makers, Inc. · Gastroenterology & Urology device
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Jul 1979
Decision
35d
Days
Class 2
Risk

K791182 is an FDA 510(k) clearance for the ACMI RIGI-FLEX NEPHORSCOPE. Classified as Kit, Nephroscope (product code FGA), Class II - Special Controls.

Submitted by American Cystocope Makers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 American Cystocope Makers, Inc. devices

Submission Details

510(k) Number K791182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date July 30, 1979
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGA Kit, Nephroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGA Kit, Nephroscope

Devices cleared under the same product code (FGA) and FDA review panel - the closest regulatory comparables to K791182.
KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
K950433 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
K940594 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486 · Olympus Corp. · Sep 1985
PYELOSCOPE SYSTEM
K770729 · Richard Wolf Medical Instruments Corp. · Apr 1977