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510(k) K890443

CASPAR SCALP CLIP, APPLIER by Aesculap Instruments Corp. — Product Code HBO

K890443 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "CASPAR SCALP CLIP, APPLIER". The FDA issued a decision of Substantially Equivalent on June 15, 1989. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1989
Date Received
January 27, 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 by Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K884057 — ELAN-E DISPOSABLE DRAPE (October 19, 1988)
  • K880704 — CERULLO SUCTION REGULATOR (March 29, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801886 — BURR, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

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)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K881265 — RANEY CLIPS (May 31, 1988)

FDA data resources