Cleared Traditional

K011073 - CRYOPLAN SYSTEM

K011073 is an FDA 510(k) clearance for CRYOPLAN SYSTEM, manufactured by Cryomedical Sciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K011073 · Cryomedical Sciences, Inc. · General & Plastic Surgery device
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Aug 2001
Decision
135d
Days
Class 2
Risk

K011073 is an FDA 510(k) clearance for the CRYOPLAN SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryomedical Sciences, Inc. (Crofton, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - 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 Cryomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K011073

510(k) Number K011073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2001
Decision Date August 22, 2001
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 - GEH Unit, Cryosurgical, Accessories

All 165
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K011073.
CRYOCARE SURGICAL SYSTEM
K011074 · Endocare, Inc. · Jan 2002
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · Galil Medical , Ltd. · Oct 2001
CRYOCARE SURGICAL SYSTEM
K003811 · Endocare, Inc. · Oct 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · Galil Medical , Ltd. · May 2001
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · Galil Medical , Ltd. · Oct 2000