Cleared Traditional

K951105 - KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951105 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
224d
Days
Class 2
Risk

K951105 is an FDA 510(k) clearance for the KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 224 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K951105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date October 20, 1995
Days to Decision 224 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
64d slower than avg
Panel avg: 160d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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.