Cleared Traditional

K930474 - NEEDLE, PNEUMOPERITONEUM, SPRING LOADED

K930474 is an FDA 510(k) clearance for NEEDLE, manufactured by Ranfac, Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FHO cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K930474 · Ranfac, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
176d
Days
Class 2
Risk

K930474 is an FDA 510(k) clearance for the NEEDLE, PNEUMOPERITONEUM, SPRING LOADED. Classified as Pneumoperitoneum Needle (product code FHO), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on July 23, 1993 after a review of 176 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Ranfac, Corp. devices

FDA 510(k) Submission Details - K930474

510(k) Number K930474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1993
Decision Date July 23, 1993
Days to Decision 176 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
45d slower than avg
Panel avg: 131d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHO Device Classification - Class 2, Special Controls

Product Code FHO Pneumoperitoneum Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition For Establishment Of A Pneumoperitoneum In Abdomen.
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 - FHO Pneumoperitoneum Needle

All 10
Devices cleared under the same product code (FHO) and FDA review panel - the closest regulatory comparables to K930474.
PNEUMO-MATIC INSUFFLATION NEEDLE
K970788 · Apple Medical Corp. · Mar 1997
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
K960574 · Sherwood Medical Co. · Aug 1996
VERRES NEEDLE
K942484 · Linvatec Corp. · Jun 1994
CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE
K915725 · Clarus Medical Systems, Inc. · Nov 1992
ENTREE NEEDLE
K914426 · Core Dynamics, Inc. · Nov 1991
ORIGINEEDLE, MODIFICATION
K913816 · Origin Medsystems, Inc. · Nov 1991