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510(k) K253814

Raney Clips Kit by Beijing Honghugaoxiang Science and Technology Development CO — Product Code HBO

K253814 is an FDA 510(k) premarket notification submitted by Beijing Honghugaoxiang Science and Technology Development CO for the device "Raney Clips Kit". The FDA issued a decision of Substantially Equivalent on July 21, 2026. 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
July 21, 2026
Date Received
November 28, 2025
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)
  • 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