Cleared Traditional

K960347 - SAFETY TROCER WITH SPRINGLOADED OBDURATOR

K960347 is the FDA 510(k) clearance for SAFETY TROCER WITH SPRINGLOADED OBDURATOR by Spiess Design, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K960347 · Spiess Design, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
158d
Days
Class 2
Risk

K960347 is an FDA 510(k) clearance for the SAFETY TROCER WITH SPRINGLOADED OBDURATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Spiess Design, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 158 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 Spiess Design, Inc. devices

Submission Details

510(k) Number K960347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date July 01, 1996
Days to Decision 158 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
2d faster than avg
Panel avg: 160d · This submission: 158d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K960347.
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K960262 · Cook Urological, Inc. · Apr 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc. · Apr 1996