510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HRXClass II

Arthroscope

21 CFR 888.1100 / Orthopedic
FDA source (opens on fda.gov)

HRX is the FDA product code for Arthroscope, a class II device type, regulated under 21 CFR 888.1100. FDA's definition for this code reads: "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)". As of , FDA records hold 683 510(k) clearances under this code, the most recent dated , and 126 recalls.

Classification record

Product code
HRX
Device name
Arthroscope
FDA 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).
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
683
Ingested recalls
126

Clearances, product code HRX

By decision year
683 clearances under product code HRX with a decision year between 1977 and 2026, 1995 the highest year at 84.
Show the numbers
510(k) clearances under FDA product code HRX by decision year
YearClearances
19772
19813
19828
198315
19847
19855
198620
198713
198815
198916
199027
199122
199214
199330
199473
199584
199624
199718
199816
199921
200015
200127
200212
200316
200411
20057
200610
20077
20089
200911
20109
20113
201211
201312
20149
20154
20168
20174
201812
201912
20207
20217
20223
20234
20246
20259
20265

Applicants with the most clearances

Product code HRX
Applicants holding the most 510(k) clearances under product code HRX
ApplicantClearances
Karl Storz Endoscopy-America, Inc.33
Arthrex GmbH27
Acufex Microsurgical, Inc.26
Stryker Corp.24
Linvatec Corporation19
Smith & Nephew, Inc.19
Richard Wolf Medical Instruments Corp.14
Smith & Nephew Dyonics, Inc.14
Concept, Inc.10
Downs Surgical, Ltd.10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 331 companies shown, in name order