Cleared Traditional

K941208 - DIAGNOSTIC SLEEVE, REDUCER SLEEVE

K941208 is an FDA 510(k) clearance for DIAGNOSTIC SLEEVE, 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 95-day FDA review.

K941208 · New Eder Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
95d
Days
Class 2
Risk

K941208 is an FDA 510(k) clearance for the DIAGNOSTIC SLEEVE, REDUCER SLEEVE. 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 June 17, 1994 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all New Eder Corp. devices

FDA 510(k) Submission Details - K941208

510(k) Number K941208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date June 17, 1994
Days to Decision 95 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
65d faster than avg
Panel avg: 160d · This submission: 95d
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 K941208.
VIDEO ENDOSCOPE-RIGID MODIFICATION
K921294 · Medical Dynamics, Inc. · Jul 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology · Jun 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K940505 · Uresil Corp. · Jun 1994
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
K941334 · Davol, Inc. · Jun 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
K923260 · Imtec Corp. · Jun 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
K940709 · Baxter Healthcare Corp · May 1994