Cleared Traditional

K983527 - MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE

K983527 is an FDA 510(k) clearance for MICROENDOSCOPE, manufactured by Dofi Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K983527 · Dofi Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
103d
Days
Class 2
Risk

K983527 is an FDA 510(k) clearance for the MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Dofi Technologies, Inc. (New York, US). The FDA issued a Cleared decision on January 19, 1999 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dofi Technologies, Inc. devices

FDA 510(k) Submission Details - K983527

510(k) Number K983527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1998
Decision Date January 19, 1999
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 949
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K983527.
HERMES OPERATING ROOM CONTROL CENTER
K990691 · Computer Motion, Inc. · Mar 1999
MEDIVISION LAPAROSCOPE
K984434 · Medivision Scope Service Center, Inc. · Mar 1999
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
K990379 · Dexide, Inc. · Mar 1999
3-CHIP VIDEO CAMERA
K983566 · Stryker Endoscopy · Jan 1999
IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM
K983567 · Med Images, Inc. · Jan 1999
DCI ENDOSCOPE
K983363 · KARL STORZ Endoscopy-America, Inc. · Dec 1998