Cleared Traditional

K881715 - 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES

K881715 is an FDA 510(k) clearance for 28200 SERIES MICRO-ARTHRO. STERILE DISP..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K881715 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
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Aug 1988
Decision
131d
Days
Class 2
Risk

K881715 is an FDA 510(k) clearance for the 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K881715

510(k) Number K881715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1988
Decision Date August 30, 1988
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K881715.
EDWARDS ARTHROSCOPIC LEG HOLDER
K884302 · Baxter Healthcare Corp · Nov 1988
IRRIGATION SET
K883300 · Edwards Orthopaedics Div., Baxter Healthcare Corp. · Nov 1988
ARTHRO-TRAC(TM)
K883361 · Rudolph Beaver, Inc. · Oct 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988
CANNULA MODEL AR-6551
K881792 · Arthrex Arthroscopy Instruments, Inc. · Jul 1988
CANNULA MODEL AR-6001
K880295 · Arthrex Arthroscopy Instruments, Inc. · Jun 1988
K881715 · 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
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