Cleared Traditional

K954774 - SHIELDED TROCAR (OBTURATOR)

K954774 is an FDA 510(k) clearance for SHIELDED TROCAR (OBTURATOR), manufactured by Gabris Surgical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K954774 · Gabris Surgical Corp. · Obstetrics & Gynecology device
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Jun 1996
Decision
234d
Days
Class 2
Risk

K954774 is an FDA 510(k) clearance for the SHIELDED TROCAR (OBTURATOR). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gabris Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 234 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 Gabris Surgical Corp. devices

FDA 510(k) Submission Details - K954774

510(k) Number K954774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date June 07, 1996
Days to Decision 234 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
74d slower than avg
Panel avg: 160d · This submission: 234d
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 225
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K954774.
RDP-2
K961922 · Ranfac, Corp. · Aug 1996
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K960936 · Origin Medsystems, Inc. · Jul 1996
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
K960347 · Spiess Design, Inc. · Jul 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc. · May 1996
A.S.D. SAFETY TROCAR
K955412 · American Surgical Devices · May 1996
FLO-STAT FLUID MONITORING SYSTEM
K954775 · Gynecare Innovation Center · May 1996