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510(k) K822560

IRRIGATION SET by Utah Medical Products, Inc. — Product Code NBH

K822560 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "IRRIGATION SET". The FDA issued a decision of Substantially Equivalent on Dec 3, 1982. The device falls under product code NBH (Accessories, Arthroscopic), a Class I device regulated under 21 CFR 888.1100. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 3, 1982
Date Received
Aug 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Arthroscopic
Device Class
Class I
Regulation Number
888.1100
Review Panel
OR
Submission Type

Other clearances by Utah Medical Products, Inc.

  • K143424 — UTAH CVX-RIPE (Aug 28, 2015)
  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (Jan 23, 2013)
  • K101535 — BT-CATH (Jan 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (Sep 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (Jul 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (Mar 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (Feb 10, 1997)

Other clearances for product code NBH

  • K822109 — SHOVEL RETRACTOR (Jul 30, 1982)

FDA data resources