Cleared Traditional

SURGICAL PAWS (K812388) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K812388 · Berkeley Medevices · General & Plastic Surgery device
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Nov 1981
Decision
88d
Days
Class 1
Risk

K812388 is an FDA 510(k) clearance for the SURGICAL PAWS. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Berkeley Medevices (Walker, US). The FDA issued a Cleared decision on November 16, 1981 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 878.4800 - 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 Berkeley Medevices devices

Submission Details

510(k) Number K812388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date November 16, 1981
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDJ Clamp, 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 - GDJ Clamp, Surgical, General & Plastic Surgery

All 31
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K812388.
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990
AUTO SUTURE PURSE STRING APPLIER*
K874428 · United States Surgical, A Division of Tyco Healthc · Dec 1987
PROXIMATE * PSD PURSE-STRING DEVICE
K801660 · Ethicon, Inc. · Aug 1980
VESSEL OCCLUDER
K800074 · Cordis Corp. · Jan 1980