Cleared Traditional

K971518 - KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESS...

K971518 is the FDA 510(k) clearance for KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESS... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971518 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 1997
Decision
90d
Days
Class 2
Risk

K971518 is an FDA 510(k) clearance for the KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 90 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K971518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date July 24, 1997
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K971518.
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
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
K971188 · Smith & Nephew, Inc. · Jun 1997
ROLLER ELECTRODE
K954488 · Olympus America, Inc. · Mar 1997
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
K961605 · KARL STORZ Endoscopy-America, Inc. · Nov 1996