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510(k) K833651

CLIP APPLYING FORCEPS by Advanced Biosearch Assn. — Product Code HCI

K833651 is an FDA 510(k) premarket notification submitted by Advanced Biosearch Assn. for the device "CLIP APPLYING FORCEPS". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Advanced Biosearch Assn. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
October 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Aneurysm Clip
Device Class
Class II
Regulation Number
882.4175
Review Panel
NE
Submission Type

Other clearances by Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (December 12, 1988)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855030 — CHAMPY BONE PLATES & BONE SCREWS (January 30, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K853418 — SAFTI-BRACELET (September 20, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)

Other clearances for product code HCI

  • K221524 — Sugita AVM Microclip Applier (June 24, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K180914 — Aesculap Slim Clip Applier (April 17, 2018)
  • K173271 — Aesculap Slim Clip Applier Forceps (November 10, 2017)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K994191 — SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (February 8, 2000)
  • K984109 — AESCULAP AXIAL CLIP APPLIER (February 12, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K954658 — PERNECZKY CLIP APPLIER/REMOVER (October 8, 1996)
  • K940970 — YASARGIL, CASPAR, VARIO CLIP APPLIERS (January 24, 1995)

FDA data resources