Cleared Traditional

K981130 - KSEA ENDO TIP SYSTEM

K981130 is the FDA 510(k) clearance for KSEA ENDO TIP SYSTEM by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K981130 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
142d
Days
Class 2
Risk

K981130 is an FDA 510(k) clearance for the KSEA ENDO TIP SYSTEM. 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 August 19, 1998 after a review of 142 days - within the typical 510(k) review window.

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 K981130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date August 19, 1998
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K981130.
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc. · Apr 1999
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · Smith & Nephew, Inc. · Sep 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763 · Deroyal Industries, Inc. · Jul 1998
KSEA PLASTIC TROCARS
K980694 · KARL STORZ Endoscopy-America, Inc. · May 1998
CO2 PNEUMO-DISSECTOR
K972647 · Cook Urological, Inc. · Apr 1998