Cleared Traditional

K990004 - DCI ENDOSCOPE

K990004 is the FDA 510(k) clearance for DCI ENDOSCOPE 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 88-day FDA review.

K990004 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
88d
Days
Class 2
Risk

K990004 is an FDA 510(k) clearance for the DCI ENDOSCOPE. 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 April 2, 1999 after a review of 88 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.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K990004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date April 02, 1999
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K990004.
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · Xomed, Inc. · Jun 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · Ethicon Endo-Surgery, Inc. · May 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · Smith & Nephew, Inc. · Sep 1998
KSEA ENDO TIP SYSTEM
K981130 · KARL STORZ Endoscopy-America, Inc. · Aug 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763 · Deroyal Industries, Inc. · Jul 1998