Cleared Traditional

K972210 - RESECTOSCOPE SAFETY SHEATH

K972210 is an FDA 510(k) clearance for RESECTOSCOPE SAFETY SHEATH, manufactured by Conceptus, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972210 · Conceptus, Inc. · Obstetrics & Gynecology device
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Sep 1997
Decision
86d
Days
Class 2
Risk

K972210 is an FDA 510(k) clearance for the RESECTOSCOPE SAFETY SHEATH. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conceptus, Inc. devices

FDA 510(k) Submission Details - K972210

510(k) Number K972210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1997
Decision Date September 05, 1997
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
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 132
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K972210.
GALILEO DISPOSABLE HYSTEROSCOPES
K974297 · Netoptix Corp. · Feb 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
MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
K972426 · Imagyn Medical, Inc. · Sep 1997
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
K971305 · Gynecare Innovation Center · Aug 1997
ELECTROSURGICAL ELECRTRODES
K962271 · Northgate Technologies, Inc. · Aug 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · KARL STORZ Endoscopy-America, Inc. · Jul 1997