Cleared Traditional

K942005 - GIP/MED-GLOBE STONE EXTRACTOR BASKETS

K942005 is an FDA 510(k) clearance for GIP/MED-GLOBE STONE EXTRACTOR BASKETS, manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K942005 · Medi-Globe Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
211d
Days
Class 2
Risk

K942005 is an FDA 510(k) clearance for the GIP/MED-GLOBE STONE EXTRACTOR BASKETS. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: 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 Medi-Globe Corp. devices

FDA 510(k) Submission Details - K942005

510(k) Number K942005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date November 22, 1994
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQR Device Classification - Class 2, Special Controls

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - LQR Dislodger, Stone, Biliary

All 26
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K942005.
SPYCATCH STONE RETRIEVAL BASKET
K071066 · Boston Scientific Corp · Jun 2007
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
ENDOSCOPIC BILIARY CATHETER
K946358 · Boston Scientific Corp · Apr 1995
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · Boston Scientific Corp · Feb 1993
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · Boston Scientific Corp · Dec 1992
GLASSMAN STONE EXTRACTION SET
K904472 · Wilson-Cook Medical, Inc. · Dec 1990