Cleared Traditional

K881014 - THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM

K881014 is an FDA 510(k) clearance for THE KARL STORZ MINI 9000 SOLID STATE CC..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K881014 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
35d
Days
Class 1
Risk

K881014 is an FDA 510(k) clearance for the THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 - K881014

510(k) Number K881014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date April 14, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

FWF Device Classification - Class 1, General Controls

Product Code FWF Camera, Television, Endoscopic, Without Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FWF Camera, Television, Endoscopic, Without Audio

All 22
Devices cleared under the same product code (FWF) and FDA review panel - the closest regulatory comparables to K881014.
3DSCOPE
K923160 · American Surgical Technologies Corp. · Dec 1992
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
K911163 · Imagyn Medical, Inc. · Jun 1991
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
K905393 · Frigitronics, Inc. · Jan 1991
RGB CAMERA SYSTEM
K872661 · Aspen Laboratories, Inc. · Jul 1987
MEDICAM S-4 SURGICAL CAMERA
K871056 · M.P. Video, Inc. · Mar 1987
MODEL MC-1 SURGICAL VIDEO CAMERA
K863376 · Biometric Products, Inc. · Oct 1986
K881014 · THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
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