Cleared Traditional

K881783 - KLEIN HANDLE

K881783 is an FDA 510(k) clearance for KLEIN HANDLE, manufactured by E.L. Medico Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K881783 · E.L. Medico Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
220d
Days
Class 1
Risk

K881783 is an FDA 510(k) clearance for the KLEIN HANDLE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by E.L. Medico Intl., Inc. (San Clemente, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 220 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 E.L. Medico Intl., Inc. devices

FDA 510(k) Submission Details - K881783

510(k) Number K881783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date December 02, 1988
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GDM Needle, Aspiration And Injection, Reusable

All 25
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K881783.
PLEURA BIOPSY DEVICE
K901995 · Mill-Rose Laboratory · Jul 1990
ROCKET BONE MARROW NEEDLE
K895551 · A & A Medical, Inc. · Oct 1989
CORE BIOPSY NEEDLE, CATALOG CODE #54006
K891537 · Dlp, Inc. · Apr 1989
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC
K882240 · Storz Instrument Co. · Jul 1988
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
K882601 · E-Z-Em, Inc. · Jul 1988
SPINAL NEEDLE
K882073 · Karlin Technology, Inc. · Jul 1988