Cleared Traditional

K953364 - SPECULITE

K953364 is an FDA 510(k) clearance for SPECULITE, manufactured by Trylon Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K953364 · Trylon Corp. · Obstetrics & Gynecology device
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Dec 1995
Decision
144d
Days
Class 2
Risk

K953364 is an FDA 510(k) clearance for the SPECULITE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Trylon Corp. (Monarch Beach, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 144 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 Trylon Corp. devices

FDA 510(k) Submission Details - K953364

510(k) Number K953364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date December 08, 1995
Days to Decision 144 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
16d faster than avg
Panel avg: 160d · This submission: 144d
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 226
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K953364.
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R-MED ABDOMINAL WALL ELEVATOR
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OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
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KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc. · Oct 1995