Cleared Traditional

K991377 - OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCO...

K991377 is an FDA 510(k) clearance for OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCO..., manufactured by Omnisonics Medical Technologies. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K991377 · Omnisonics Medical Technologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
82d
Days
Class 2
Risk

K991377 is an FDA 510(k) clearance for the OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Omnisonics Medical Technologies (N. Reading, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 82 days - a notably fast clearance cycle.

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: 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 Omnisonics Medical Technologies devices

FDA 510(k) Submission Details - K991377

510(k) Number K991377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date July 12, 1999
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K991377.
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
K991718 · Richard Wolf Medical Instruments Corp. · Aug 1999
BLUNT TIP TROCAR PORT
K992353 · Origin Medsystems, Inc. · Jul 1999
TROCAR SYSTEM ACCORDING TO HASSON
K990237 · Olympus America, Inc. · Jul 1999
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K991928 · Allegiance Healthcare Corp. · Jun 1999
DCI ENDOSCOPE
K991171 · Karl Storz Endoscopy · Jun 1999
DCI ENDOSCOPE
K991228 · Karl Storz Endoscopy · Jun 1999