Cleared Traditional

K980676 - SPIGAL NEEDLE

K980676 is an FDA 510(k) clearance for SPIGAL NEEDLE, manufactured by Gallini U.S., LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980676 · Gallini U.S., LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980676 is an FDA 510(k) clearance for the SPIGAL NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Gallini U.S., LLC (Richmond, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Gallini U.S., LLC devices

FDA 510(k) Submission Details - K980676

510(k) Number K980676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date May 21, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 306
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K980676.
DAUM BONE BIOPSY SET
K981320 · Daum Corp. · Jun 1998
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
K981166 · Inrad · Jun 1998
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
K981477 · Medical Biopsy, Inc. · Jun 1998
QUICK-CUT AUTOMATIC BIOPSY SYSTEM
K980479 · Gallini U.S., LLC · May 1998
PUNCTURENEEDLE
K963794 · Ferguson Medical · Mar 1998
DAUM NEUROBIOPSY NEEDLE
K974631 · Daum Corp. · Mar 1998