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510(k) K896723

CLIP GUN WITH RANEY TYPE SCALP CLIPS by Omni Medical Designs — Product Code HBO

K896723 is an FDA 510(k) premarket notification submitted by Omni Medical Designs for the device "CLIP GUN WITH RANEY TYPE SCALP CLIPS". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1990
Date Received
November 29, 1989
Clearance Type
Traditional
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 for product code HBO

  • K050044 — MEDTRONIC CLIP GUN KIT (February 7, 2005)
  • 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)
  • 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