Cleared Traditional

K071127 - FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH S...

K071127 is the FDA 510(k) clearance for FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH S... by Vision-Sciences, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K071127 · Vision-Sciences, Inc. · Obstetrics & Gynecology device
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Nov 2007
Decision
207d
Days
Class 2
Risk

K071127 is an FDA 510(k) clearance for the FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Ayer, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 207 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 Vision-Sciences, Inc. devices

Submission Details

510(k) Number K071127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date November 16, 2007
Days to Decision 207 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
47d slower than avg
Panel avg: 160d · This submission: 207d
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 99
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K071127.
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc. · Nov 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · Smith & Nephew, Inc. · Mar 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc. · Mar 2011
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy · May 2004
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
K033113 · Richard Wolf Medical Instruments Corp. · Dec 2003