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510(k) K881911

NEW SIZES SUGITA CLIPS by Downs Surgical , Ltd. — Product Code HCI

K881911 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "NEW SIZES SUGITA CLIPS". The FDA issued a decision of Substantially Equivalent on June 6, 1988. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1988
Date Received
May 9, 1988
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 Downs Surgical , Ltd.

  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900612 — SHEPPERD TREPHINE SET (GS-501-30-V) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900616 — SHEPPERD CUTTING FORCEPS (October 22, 1990)

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