Cleared Traditional

K973621 - PRE-VIEW CHOLANGIOGRAPHY CLAMP

K973621 is an FDA 510(k) clearance for PRE-VIEW CHOLANGIOGRAPHY CLAMP, manufactured by Nashville Surgical Instruments. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973621 · Nashville Surgical Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
85d
Days
Class 1
Risk

K973621 is an FDA 510(k) clearance for the PRE-VIEW CHOLANGIOGRAPHY CLAMP. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Nashville Surgical Instruments (Springfield, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Nashville Surgical Instruments devices

FDA 510(k) Submission Details - K973621

510(k) Number K973621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1997
Decision Date December 17, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

GBZ Device Classification - Class 1, General Controls

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBZ Catheter, Cholangiography

All 17
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K973621.
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K944790 · Applied Medical Resources · Nov 1994
ENDOPATH
K942450 · Ethicon Endo-Surgery, Inc. · Aug 1994
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
K932228 · Boston Scientific Corp · Aug 1993
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K926217 · Terumo Medical Corp. · Jul 1993
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · Stryker Corp. · Jul 1993
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1993