Cleared Traditional

K820290 - SELF RETAINING RETRACTOR FOR HAND SURG

K820290 is the FDA 510(k) clearance for SELF RETAINING RETRACTOR FOR HAND SURG by The Anspach Effort, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAD) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K820290 · The Anspach Effort, Inc. · General & Plastic Surgery device
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Mar 1982
Decision
30d
Days
Class 1
Risk

K820290 is an FDA 510(k) clearance for the SELF RETAINING RETRACTOR FOR HAND SURG. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982 after a review of 30 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K820290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1982
Decision Date March 05, 1982
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 34
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K820290.
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46
K834181 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
K834196 · Imm Enterprises , Ltd. · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
ARTHROSCOPIC FAT PAD RETRACTOR
K802599 · The Anspach Effort, Inc. · Oct 1980
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980
DEEP BALFOUR BLADE FOR WILKINSON RETRACT
K801611 · Edward Weck, Inc. · Aug 1980