Cleared Traditional

K780624 - CULDOCENTESIS TRAY

K780624 is an FDA 510(k) clearance for CULDOCENTESIS TRAY, manufactured by Cutter Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K780624 · Cutter Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1978
Decision
42d
Days
Class 1
Risk

K780624 is an FDA 510(k) clearance for the CULDOCENTESIS TRAY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 42 days - a notably fast clearance 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: 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 Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K780624

510(k) Number K780624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1978
Decision Date May 26, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 41
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K780624.
NEEDLE II, BURRON FILTER
K790060 · National Patent Development Corp. · Mar 1979
NEEDLE, WITH FILTER
K790142 · National Patent Development Corp. · Feb 1979
NEEDLE, BURRON FILTER
K790061 · National Patent Development Corp. · Feb 1979
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977
TERUMO DISPOSABLE SPINAL NEEDLE
K760775 · Terumo America, Inc. · Nov 1976