Cleared Traditional

K961688 - MICROSPAN HYSTEROSCOPE

K961688 is an FDA 510(k) clearance for MICROSPAN HYSTEROSCOPE, manufactured by Imagyn Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K961688 · Imagyn Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
167d
Days
Class 2
Risk

K961688 is an FDA 510(k) clearance for the MICROSPAN HYSTEROSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 167 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 Imagyn Medical, Inc. devices

FDA 510(k) Submission Details - K961688

510(k) Number K961688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date October 15, 1996
Days to Decision 167 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
7d slower than avg
Panel avg: 160d · This submission: 167d
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 K961688.
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
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