Cleared Traditional

K915762 - POOLE TIP SUCTION PROBE

K915762 is an FDA 510(k) clearance for POOLE TIP SUCTION PROBE, manufactured by O.R. Concepts, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K915762 · O.R. Concepts, Inc. · General & Plastic Surgery device
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Mar 1992
Decision
80d
Days
Class 2
Risk

K915762 is an FDA 510(k) clearance for the POOLE TIP SUCTION PROBE. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 80 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K915762

510(k) Number K915762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date March 13, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCI Device Classification - Class 2, Special Controls

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 K915762.
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
K922123 · United States Surgical, A Division of Tyco Healthc · Feb 1993
GLEESON CLOT-BUSTER
K920139 · Conmedcorp · Apr 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