510(k) K871181

ARTHROCOMBI 5003 by F.M. Wiest USA, Inc. — Product Code HRX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 29, 1987
Date Received: March 25, 1987
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Arthroscope
Device Class: Class II
Regulation Number: 888.1100
Review Panel: OR
Submission Type

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).

Other clearances by F.M. Wiest USA, Inc.

K921871 — HYSTEROMAT(TM) 3700 (December 15, 1994)
K920574 — CAMSYS 6300 (February 17, 1993)
K920575 — MERKUR 4000 (July 23, 1992)
K915751 — URETEROMAT 4400 (April 24, 1992)
K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
K912071 — SPACE(TM) 7500 (July 9, 1991)
K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
K865066 — ARTHROFLATOR (April 20, 1987)

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K252666 — Articulator Arthroscopic Bur (November 21, 2025)
K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
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K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
K241990 — SpineSite Endoscope System (July 30, 2025)
K243602 — Arthrex Spine Endoscope (May 16, 2025)