Cleared Traditional

K770058 - PROBE

K770058 is the FDA 510(k) clearance for PROBE by Spembly Medical , Ltd.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K770058 · Spembly Medical , Ltd. · General & Plastic Surgery device
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Feb 1977
Decision
37d
Days
Class 2
Risk

K770058 is an FDA 510(k) clearance for the PROBE, VACUUM INSULATED, SERIES 30. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Spembly Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1977 after a review of 37 days - a notably fast clearance cycle.

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: 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 Spembly Medical , Ltd. devices

Submission Details

510(k) Number K770058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1977
Decision Date February 17, 1977
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.