Cleared Traditional

K812389 - SURGICAL LOOPS

K812389 is the FDA 510(k) clearance for SURGICAL LOOPS by Berkeley Medevices. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K812389 · Berkeley Medevices · General & Plastic Surgery device
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Nov 1981
Decision
88d
Days
Class 1
Risk

K812389 is an FDA 510(k) clearance for the SURGICAL LOOPS. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Berkeley Medevices (Mchenry, 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.

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Submission Details

510(k) Number K812389 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 GAD Retractor
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 - GAD Retractor

All 39
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K812389.
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
PILLING IDENTI-LOOPS
K820377 · Narco Scientific · Mar 1982
SELF RETAINING RETRACTOR FOR HAND SURG
K820290 · The Anspach Effort, Inc. · Mar 1982
RETRACTING PROBES
K811759 · American V. Mueller · Jul 1981
ARTHROSCOPIC FAT PAD RETRACTOR
K802599 · The Anspach Effort, Inc. · Oct 1980
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980