Cleared Traditional

K981956 - DEGANIA SILICONE IDENTI LOOPS

K981956 is an FDA 510(k) clearance for DEGANIA SILICONE IDENTI LOOPS, manufactured by Degania Silicone , Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K981956 · Degania Silicone , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
35d
Days
Class 2
Risk

K981956 is an FDA 510(k) clearance for the DEGANIA SILICONE IDENTI LOOPS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on July 9, 1998 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Degania Silicone , Ltd. devices

FDA 510(k) Submission Details - K981956

510(k) Number K981956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date July 09, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 163
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K981956.
CAOW HEMOSTASIS SYSTEM
K972689 · Anlam Corp. · Aug 1998
FLO-THRU
K981624 · Bio-Vascular, Inc. · Aug 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · Cardio Medical Solutions, Inc. · Jul 1998
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
K980087 · Pressure Products, Inc. · Jul 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · Boss Instruments, Ltd. · Jun 1998
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998