Cleared Traditional

K964276 - ENDOSCOPIC HYSTERECTOMY AND UTERUS MANI...

K964276 is the FDA 510(k) clearance for ENDOSCOPIC HYSTERECTOMY AND UTERUS MANI... by Richard Wolf Medical Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HEW) cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K964276 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
393d
Days
Class 2
Risk

K964276 is an FDA 510(k) clearance for the ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1640 - 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. Elevated predicate reliance profile. 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K964276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date November 25, 1997
Days to Decision 393 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
233d slower than avg
Panel avg: 160d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEW Culdoscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1640
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 - HEW Culdoscope (and Accessories)

All 10
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K964276.
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · CooperSurgical, Inc. · Jul 2015
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc. · Feb 2004
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc. · Feb 2000
KOH COLPOTOMIZER SYSTEM
K954311 · CooperSurgical, Inc. · Nov 1996
KSEA CULDOCENTESIS SET
K962881 · Karl Storz Endoscopy · Oct 1996