Cleared Traditional

K812562 - SURGICAL RETRACTOR & ELASTIC STAYS

K812562 is an FDA 510(k) clearance for SURGICAL RETRACTOR & ELASTIC STAYS, manufactured by Humboldt Products. The device is a Class 1 General & Plastic Surgery device with product code GDG cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K812562 · Humboldt Products · General & Plastic Surgery device
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Oct 1981
Decision
24d
Days
Class 1
Risk

K812562 is an FDA 510(k) clearance for the SURGICAL RETRACTOR & ELASTIC STAYS, DISP. Classified as Hook, Surgical, General & Plastic Surgery (product code GDG), Class I - General Controls.

Submitted by Humboldt Products (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 24 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 Humboldt Products devices

FDA 510(k) Submission Details - K812562

510(k) Number K812562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1981
Decision Date October 02, 1981
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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

All 7
Devices cleared under the same product code (GDG) and FDA review panel - the closest regulatory comparables to K812562.
MODIFIED PGL ABSORBABLE STAPLE*
K900069 · United States Surgical, A Division of Tyco Healthc · Apr 1990
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