Cleared Traditional

K910622 - GESCO PER-Q-CATH REPAIR KIT

K910622 is an FDA 510(k) clearance for GESCO PER-Q-CATH REPAIR KIT, manufactured by Gesco Intl., Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K910622 · Gesco Intl., Inc. · General Hospital
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Mar 1991
Decision
45d
Days
Class 2
Risk

K910622 is an FDA 510(k) clearance for the GESCO PER-Q-CATH REPAIR KIT. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 Gesco Intl., Inc. devices

FDA 510(k) Submission Details - K910622

510(k) Number K910622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 12, 1991
Decision Date March 29, 1991
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 213
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K910622.
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