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510(k) K942101

4-LEAD IRRIGATION SET by Douglas Medical Products Corp. — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
May 2, 1994
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 Douglas Medical Products Corp.

  • K162951 — TUBETECH IV Administration Set (July 28, 2017)
  • K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 (June 18, 1996)
  • K954428 — SOLOPICC 24 (60CM) 20GA CATHETER (March 28, 1996)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K941453 — CHECK VALVE SOLUTION SET (August 16, 1994)
  • K930854 — SOLUTION SET WITH .2 MICRON FILTER (January 14, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

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  • K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
  • K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
  • K241990 — SpineSite Endoscope System (July 30, 2025)
  • K243602 — Arthrex Spine Endoscope (May 16, 2025)