Cleared Traditional

K951946 - HYSTEROSYS FLEXIBLE HYSTEROCOPE

K951946 is an FDA 510(k) clearance for HYSTEROSYS FLEXIBLE HYSTEROCOPE, manufactured by Ovamed Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K951946 · Ovamed Corp. · Obstetrics & Gynecology device
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Nov 1995
Decision
208d
Days
Class 2
Risk

K951946 is an FDA 510(k) clearance for the HYSTEROSYS FLEXIBLE HYSTEROCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Ovamed Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 208 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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 Ovamed Corp. devices

FDA 510(k) Submission Details - K951946

510(k) Number K951946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date November 20, 1995
Days to Decision 208 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
48d slower than avg
Panel avg: 160d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 - HIH Hysteroscope (and Accessories)

All 110
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K951946.
ROLLER ELECTRODE
K954488 · Olympus America, Inc. · Mar 1997
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
K961605 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K955119 · Symbiosis Corp. · Jan 1996
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
K935716 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
KARL STORZ FLEXIBLE HYSTERSCOPE
K952779 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
HAND EXTRACTOR HECTOR
K953109 · Karl Storz Endoscopy · Aug 1995