Cleared Traditional

SKIN STAPLE REMOVER KIT (K915430) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K915430 · Cypress Medical Products, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
88d
Days
Class 1
Risk

K915430 is an FDA 510(k) clearance for the SKIN STAPLE REMOVER KIT. Classified as Staple, Removable (skin) (product code GDT), Class I - General Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on February 28, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4760 - 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 Cypress Medical Products, Ltd. devices

Submission Details

510(k) Number K915430 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 02, 1991
Decision Date February 28, 1992
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDT Staple, Removable (skin)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.