Cleared Traditional

K922123 - AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECI...

K922123 is the FDA 510(k) clearance for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECI... by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GCI) cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K922123 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
271d
Days
Class 2
Risk

K922123 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 271 days - an extended review 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: 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K922123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date February 01, 1993
Days to Decision 271 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
156d slower than avg
Panel avg: 115d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCI Laryngoscope, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCI Laryngoscope, Endoscope

Devices cleared under the same product code (GCI) and FDA review panel - the closest regulatory comparables to K922123.
GLEESON CLOT-BUSTER
K920139 · Conmedcorp · Apr 1992
POOLE TIP SUCTION PROBE
K915762 · O.R. Concepts, Inc. · Mar 1992
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
K914120 · Conmedcorp · Oct 1991
ENDOSTAPLE
K911829 · Ethicon, Inc. · Aug 1991
ENDOSCOPE AND ACCESSORIES
K905117 · Northgate Technologies, Inc. · Apr 1991
MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE
K896205 · Dexide, Inc. · Mar 1990