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510(k) K050044

MEDTRONIC CLIP GUN KIT by Medtronic Neurosurgery — Product Code HBO

K050044 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "MEDTRONIC CLIP GUN KIT". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
January 10, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Scalp
Device Class
Class II
Regulation Number
882.4150
Review Panel
NE
Submission Type

Other clearances by Medtronic Neurosurgery

  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242034 — Duet External Drainage and Monitoring System (EDMS) (October 24, 2024)
  • K212641 — StrataMR II Valves and Shunts (September 16, 2021)
  • K181622 — StrataMR guider tool (October 1, 2018)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K152700 — StrataMR Valves and Shunts (April 7, 2016)
  • DEN120017 — Medtronic DUET External Drainage and Monitoring System (August 22, 2014)
  • K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (February 13, 2013)
  • K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (November 18, 2011)
  • K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (September 2, 2009)

Other clearances for product code HBO

  • K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (January 7, 2004)
  • K012219 — SCALPFIX CLIP SYSTEM (July 31, 2001)
  • K944311 — ACRA-CUT (November 18, 1994)
  • K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER (February 21, 1991)
  • K896723 — CLIP GUN WITH RANEY TYPE SCALP CLIPS (March 23, 1990)
  • K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (December 6, 1989)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K881265 — RANEY CLIPS (May 31, 1988)

FDA data resources