Cleared Traditional

K953190 - KSEA MODEL 203200 20 UNIMAT

K953190 is an FDA 510(k) clearance for KSEA MODEL 203200 20 UNIMAT, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K953190 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
87d
Days
Class 2
Risk

K953190 is an FDA 510(k) clearance for the KSEA MODEL 203200 20 UNIMAT. 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 5, 1995 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K953190

510(k) Number K953190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date October 05, 1995
Days to Decision 87 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
74d faster than avg
Panel avg: 161d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K953190.
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
MICROSURGE VERESS NEEDLE
K954520 · Microsurge, Inc. · Oct 1995
LAPOROSCOPIC SCISSORS
K942431 · Enterprise Medical Corp. · Oct 1995
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
K953574 · American Hydro-Surgical Instruments, Inc. · Sep 1995
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265 · Cook Urological, Inc. · Sep 1995
LAPAROSCOPIC SURGICAL INSTRUMENT
K953548 · Gabris Surgical Corp. · Sep 1995
K953190 · KSEA MODEL 203200 20 UNIMAT
Download PDF FDA Summary KARL STORZ Endoscopy-…