Cleared Traditional

K000806 - KARL STORZ HYSTEROMAT II

K000806 is the FDA 510(k) clearance for KARL STORZ HYSTEROMAT II by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIG) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K000806 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Nov 2000
Decision
262d
Days
Class 2
Risk

K000806 is an FDA 510(k) clearance for the KARL STORZ HYSTEROMAT II. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 30, 2000 after a review of 262 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K000806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date November 30, 2000
Days to Decision 262 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 160d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 27
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K000806.
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K964136 · Richard Wolf Medical Instruments Corp. · Jan 1997
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K961091 · KARL STORZ Endoscopy-America, Inc. · Oct 1996
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K950961 · KARL STORZ Endoscopy-America, Inc. · May 1995