Cleared Traditional

K871891 - KARL STORZ MODEL 28184 PNEUMATIC SHUTTL...

K871891 is the FDA 510(k) clearance for KARL STORZ MODEL 28184 PNEUMATIC SHUTTL... by KARL STORZ Endoscopy-America, Inc.. It is a Class 1 Orthopedic device (product code HSZ) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K871891 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
21d
Days
Class 1
Risk

K871891 is an FDA 510(k) clearance for the KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K871891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1987
Decision Date June 05, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K871891.
ACE PNEUMATIC OSCILLATING SAW
K881250 · Buckman Co., Inc. · Apr 1988
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324 · Micro-Aire Surgical Instruments, Inc. · Feb 1988
1.1 COUPLERS AND 1.2 ADAPTERS
K872550 · Micro-Aire Surgical Instruments, Inc. · Jul 1987
ORTHOPEDIC DRILL GUIDE
K871287 · Orthopedic Systems, Inc. · Apr 1987
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · The Anspach Effort, Inc. · Nov 1986
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986