Cleared Traditional

K891571 - PERCUSSION HAMMER

K891571 is an FDA 510(k) clearance for PERCUSSION HAMMER, manufactured by Sandal Surgico. The device is a Class 1 Neurology device with product code GWZ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K891571 · Sandal Surgico · Neurology device
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Mar 1989
Decision
11d
Days
Class 1
Risk

K891571 is an FDA 510(k) clearance for the PERCUSSION HAMMER. Classified as Percussor (product code GWZ), Class I - General Controls.

Submitted by Sandal Surgico (Sialkot, PK). The FDA issued a Cleared decision on March 31, 1989 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1700 - the FDA neurology 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 Sandal Surgico devices

FDA 510(k) Submission Details - K891571

510(k) Number K891571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date March 31, 1989
Days to Decision 11 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 148d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

GWZ Device Classification - Class 1, General Controls

Product Code GWZ Percussor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1700
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 - GWZ Percussor

All 7
Devices cleared under the same product code (GWZ) and FDA review panel - the closest regulatory comparables to K891571.
TAYLOR PERCUSSION HAMMER SS 410 OR 420
K852716 · The Huxley Instrument Corp. · Jul 1985
1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE
K851748 · Artiberia · Jun 1985
OP-CON SURG. INSTRUMENT #10
K834170 · Imm Enterprises , Ltd. · Feb 1984
H.R. JAKOBI SURG. INSTR. #10 34/36
K834178 · Imm Enterprises , Ltd. · Feb 1984
CAT 10-NEUROLOGY DEVICE
K840314 · Imm Enterprises , Ltd. · Feb 1984
CONPHAR PERCUSSION HAMMER(TAYLOR)
K803148 · Conphar, Inc. · Jan 1981