Cleared Traditional

K931793 - SYMBIOSIS ENT SURGICAL INSTRUMENTS

K931793 is an FDA 510(k) clearance for SYMBIOSIS ENT SURGICAL INSTRUMENTS, manufactured by Symbiosis Corp.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K931793 · Symbiosis Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
101d
Days
Class 1
Risk

K931793 is an FDA 510(k) clearance for the SYMBIOSIS ENT SURGICAL INSTRUMENTS. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Symbiosis Corp. devices

FDA 510(k) Submission Details - K931793

510(k) Number K931793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1993
Decision Date July 22, 1993
Days to Decision 101 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
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 slower than avg
Panel avg: 89d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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 - LRC Instrument, Ent Manual Surgical

All 54
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K931793.
DISPOSABLE NASAL SCISSOR
K942063 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994
HOUSE-BELLUCCI ALLIGATOR SCISSORS
K930292 · Thomasville Medical Assoc. · Mar 1993
ATMOS MIRROR WARMER
K920988 · Jedmed Instrument Co. · May 1992
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · Exmoor Plastics , Ltd. · Jun 1989