Cleared Traditional

K922678 - LOOP RETRIEVER

K922678 is an FDA 510(k) clearance for LOOP RETRIEVER, manufactured by Annex Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K922678 · Annex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
82d
Days
Class 2
Risk

K922678 is an FDA 510(k) clearance for the LOOP RETRIEVER. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 25, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Annex Medical, Inc. devices

FDA 510(k) Submission Details - K922678

510(k) Number K922678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date August 25, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 131d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFL Device Classification - Class 2, Special Controls

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 43
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K922678.
HELICAL STONE/FLATWIRE STONE BASKETS
K933260 · Surgitek · Jan 1994
METAL URETERAL BASKET STONE DISLODGER
K934675 · Annex Medical, Inc. · Jan 1994
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027 · Annex Medical, Inc. · Oct 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · C.R. Bard, Inc. · Apr 1992
LOOP RETRIEVER
K910603 · Annex Medical, Inc. · Mar 1991
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269 · Porges Corp. · Jul 1990