Cleared Traditional

K900069 - MODIFIED PGL ABSORBABLE STAPLE*

K900069 is an FDA 510(k) clearance for MODIFIED PGL ABSORBABLE STAPLE*, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 1 General & Plastic Surgery device with product code GDG cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K900069 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
102d
Days
Class 1
Risk

K900069 is an FDA 510(k) clearance for the MODIFIED PGL ABSORBABLE STAPLE*. Classified as Hook, Surgical, General & Plastic Surgery (product code GDG), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 102 days - within the typical 510(k) review window.

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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K900069

510(k) Number K900069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1990
Decision Date April 16, 1990
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

GDG Device Classification - Class 1, General Controls

Product Code GDG Hook, Surgical, General & Plastic Surgery
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 - GDG Hook, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GDG) and FDA review panel - the closest regulatory comparables to K900069.
SKIN HOOKS, VARIOUS TYPES
K891898 · Zinnanti Surgical Instruments, Inc. · Apr 1989
SURGICAL HOOKS, VARIOUS
K841010 · Premier Dental Products Co. · May 1984
MIDDLE EAR PICKS, HOOKS CURETTES,
K791120 · Xomed, Inc. · Jul 1979
NERVE APPROXIMATER
K780289 · Edward Weck, Inc. · Jun 1978
DERMAHOOK #382-805
K771187 · Edward Weck, Inc. · Jul 1977
ABRAMSON TRACHEA HOOK & RETRACTOR
K771190 · Edward Weck, Inc. · Jul 1977