Cleared Traditional

K970788 - PNEUMO-MATIC INSUFFLATION NEEDLE

K970788 is an FDA 510(k) clearance for PNEUMO-MATIC INSUFFLATION NEEDLE, manufactured by Apple Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FHO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K970788 · Apple Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
23d
Days
Class 2
Risk

K970788 is an FDA 510(k) clearance for the PNEUMO-MATIC INSUFFLATION NEEDLE. Classified as Pneumoperitoneum Needle (product code FHO), Class II - Special Controls.

Submitted by Apple Medical Corp. (Bolton, US). The FDA issued a Cleared decision on March 27, 1997 after a review of 23 days - a notably fast clearance 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: 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 Apple Medical Corp. devices

FDA 510(k) Submission Details - K970788

510(k) Number K970788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date March 27, 1997
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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

Devices cleared under the same product code (FHO) and FDA review panel - the closest regulatory comparables to K970788.
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
ORIGINEEDLE, MODIFICATION
K913816 · Origin Medsystems, Inc. · Nov 1991
ORIGINEEDLE(TM)
K904849 · Origin Medsystems, Inc. · Mar 1991
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330 · United States Surgical, A Division of Tyco Healthc · Oct 1986