Cleared Traditional

K983384 - DCI ENDOSCOPE

K983384 is an FDA 510(k) clearance for DCI ENDOSCOPE, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K983384 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
61d
Days
Class 2
Risk

K983384 is an FDA 510(k) clearance for the DCI ENDOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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

FDA 510(k) Submission Details - K983384

510(k) Number K983384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date November 25, 1998
Days to Decision 61 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 525
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K983384.
ARTHRO-SURGIMAT-2000 ECU
K990443 · W.O.M. World of Medicine GmbH · Feb 1999
FLEXPOSURE RETRACTOR
K983144 · Endius, Inc. · Feb 1999
KSEA C-MOUNT ARTHROSCOPES
K983142 · Karl Storz Endoscopy · Dec 1998
ARTHRO-SURGIMAT-1500
K983910 · W.O.M. World of Medicine GmbH · Nov 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · Xomed, Inc. · Nov 1998
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
K982133 · The Olympus Optical Co. · Oct 1998