Cleared Traditional

K971305 - FEMRX FOCUSED MONOPOLAR (FMP) OPERA STA...

K971305 is an FDA 510(k) clearance for FEMRX FOCUSED MONOPOLAR (FMP) OPERA STA..., manufactured by Gynecare Innovation Center. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K971305 · Gynecare Innovation Center · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
125d
Days
Class 2
Risk

K971305 is an FDA 510(k) clearance for the FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gynecare Innovation Center (Sunnyvale, US). The FDA issued a Cleared decision on August 11, 1997 after a review of 125 days - within the typical 510(k) review window.

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 Gynecare Innovation Center devices

FDA 510(k) Submission Details - K971305

510(k) Number K971305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1997
Decision Date August 11, 1997
Days to Decision 125 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
35d faster than avg
Panel avg: 160d · This submission: 125d
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 K971305.
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · KARL STORZ Endoscopy-America, Inc. · Jan 1999
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
K980302 · Richard Wolf Medical Instruments Corp. · Jul 1998
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)
K971420 · Richard Wolf Medical Instruments Corp. · Oct 1997
ELECTROSURGICAL ELECRTRODES
K962271 · Northgate Technologies, Inc. · Aug 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · KARL STORZ Endoscopy-America, Inc. · Jul 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
K971188 · Smith & Nephew, Inc. · Jun 1997