Cleared Traditional

K941206 - DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE

K941206 is an FDA 510(k) clearance for DUAL VALVE ASPIRATION/LAVAGE CANNULA AN..., manufactured by New Eder Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 498-day FDA review.

K941206 · New Eder Corp. · Obstetrics & Gynecology device
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Jul 1995
Decision
498d
Days
Class 2
Risk

K941206 is an FDA 510(k) clearance for the DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by New Eder Corp. (Elk Groove Village, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all New Eder Corp. devices

FDA 510(k) Submission Details - K941206

510(k) Number K941206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date July 25, 1995
Days to Decision 498 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 160d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K941206.
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · Olympus America, Inc. · Sep 1995
KARL STORZ SUCTION CATHETERS
K951250 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
STRYKER OPERATING LAPAROSCOPE
K943100 · Stryker Endoscopy · Aug 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K946380 · American Hydro-Surgical Instruments, Inc. · Jul 1995