Cleared Traditional

K940316 - HYSTERSCOPE

K940316 is an FDA 510(k) clearance for HYSTERSCOPE, manufactured by Stephen Chakoff, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 661-day FDA review.

K940316 · Stephen Chakoff, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
661d
Days
Class 2
Risk

K940316 is an FDA 510(k) clearance for the HYSTERSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Stephen Chakoff, Inc. (Miami, US). The FDA issued a Cleared decision on November 16, 1995 after a review of 661 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Stephen Chakoff, Inc. devices

FDA 510(k) Submission Details - K940316

510(k) Number K940316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date November 16, 1995
Days to Decision 661 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
501d slower than avg
Panel avg: 160d · This submission: 661d
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 K940316.
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
FUJINON VIDEO LAPORASCOPE
K933544 · Fujinon, Inc. · Apr 1995