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510(k) K012219

SCALPFIX CLIP SYSTEM by Aesculap, Inc. — Product Code HBO

K012219 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "SCALPFIX CLIP SYSTEM". The FDA issued a decision of Substantially Equivalent on July 31, 2001. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
July 16, 2001
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 Aesculap, Inc.

  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K214041 — Aesculap AICON Container (December 30, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K203739 — ELAN 4 Electro Motor System (August 24, 2021)
  • K202391 — DIR 800 (January 21, 2021)
  • K203461 — Aesculap Caiman 12 Seal and Cut Technology System (December 18, 2020)
  • K202938 — Aesculap Caiman 5 Seal and Cut Technology System (October 30, 2020)
  • K202124 — Aesculap PAS-Port Proximal Anastomosis System (September 2, 2020)

Other clearances for product code HBO

  • K253814 — Raney Clips Kit (July 21, 2026)
  • K050044 — MEDTRONIC CLIP GUN KIT (February 7, 2005)
  • K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (January 7, 2004)
  • 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