Cleared Traditional

INSUFFLATION NEEDLE (K963359) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963359 · Applied Medical Resources · Obstetrics & Gynecology device
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Sep 1996
Decision
29d
Days
Class 2
Risk

K963359 is an FDA 510(k) clearance for the INSUFFLATION NEEDLE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on September 24, 1996 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 Applied Medical Resources devices

Submission Details

510(k) Number K963359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date September 24, 1996
Days to Decision 29 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 160d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 109
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K963359.
KSEA UNIMAT PLUS
K963949 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
K960299 · Richard Wolf Medical Instruments Corp. · Oct 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K962090 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
A4907 LENS CLEANING SHEATH
K961860 · Olympus America, Inc. · Aug 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc. · May 1996
CORING MORCELLATOR
K960262 · Cook Urological, Inc. · Apr 1996