Cleared Traditional

FERTILOSCOPY KIT FH 1.29/FTO 1.40 (K992655) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992655 · Soprane S.A. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2000
Decision
217d
Days
Class 2
Risk

K992655 is an FDA 510(k) clearance for the FERTILOSCOPY KIT FH 1.29/FTO 1.40. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Soprane S.A. (Washington, US). The FDA issued a Cleared decision on March 13, 2000 after a review of 217 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1640 - 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 Soprane S.A. devices

Submission Details

510(k) Number K992655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date March 13, 2000
Days to Decision 217 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
57d slower than avg
Panel avg: 160d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEW Culdoscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1640
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 - HEW Culdoscope (and Accessories)

All 17
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K992655.
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152 · Applied Medical Resources Corp. · Oct 2025
Advincula Delineator Uterine Manipulator
K201086 · CooperSurgical, Inc. · May 2020
Transvaginal Access Platform
K191294 · Applied Medical Resources Corp. · Sep 2019
Advincula Delineator Uterine Manipulator
K180429 · CooperSurgical, Inc. · Mar 2018
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc. · Feb 2000