Cleared Traditional

K915378 - WECK TROCAR

K915378 is an FDA 510(k) clearance for WECK TROCAR, manufactured by Edward Weck, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K915378 · Edward Weck, Inc. · Obstetrics & Gynecology device
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Jun 1992
Decision
213d
Days
Class 2
Risk

K915378 is an FDA 510(k) clearance for the WECK TROCAR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on June 29, 1992 after a review of 213 days - an extended review 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: 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K915378

510(k) Number K915378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date June 29, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 160d · This submission: 213d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K915378.
CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
K924530 · Cabot Medical Corp. · Feb 1993
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
K915331 · United States Surgical, A Division of Tyco Healthc · Sep 1992
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · United States Surgical, A Division of Tyco Healthc · Sep 1992
TROCAR SHEATH ANCHOR
K915116 · Origin Medsystems, Inc. · Jun 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · Cook Ob/Gyn · Feb 1992
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K914968 · Ethicon, Inc. · Feb 1992