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510(k) K861711

SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE by Busse Hospital Disposables, Inc. — Product Code GDT

K861711 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE". The FDA issued a decision of Substantially Equivalent on May 16, 1986. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1986
Date Received
May 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Removable (Skin)
Device Class
Class I
Regulation Number
878.4760
Review Panel
SU
Submission Type

Other clearances by Busse Hospital Disposables, Inc.

  • K141285 — BUSSE EXTENSION SET (February 19, 2015)
  • K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (June 26, 2012)
  • K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION (June 8, 2011)
  • K093920 — BUSSE EPIDURAL CATHETER KIT (August 6, 2010)
  • K093909 — BUSSE SURGICAL DRAPES IV (May 6, 2010)
  • K092212 — BUSSE SURGICAL DRAPES III (October 9, 2009)
  • K082297 — BUSSE SURGICAL DRAPE (December 9, 2008)
  • K073222 — MODIFICATION TO:SPECIALTY NEEDLES (April 9, 2008)
  • K070465 — BUSSE EPIDURAL CATHETER (July 19, 2007)
  • K063018 — GLASS LOSS OF RESISTANCE SYRINGE (January 22, 2007)

Other clearances for product code GDT

  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K943719 — VISISTAT STAPLER (August 24, 1994)
  • K925526 — MANIPLER DISPOSABLE SKIN STAPLER (June 24, 1993)
  • K915430 — SKIN STAPLE REMOVER KIT (February 28, 1992)
  • K911204 — QUALTEX SKIN STAPLE EXTRACTOR (May 8, 1991)
  • K910586 — AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (March 7, 1991)
  • K900486 — APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER (April 20, 1990)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)
  • K844837 — VISISTAT SKIN STAPLING DEVICE (January 23, 1985)
  • K844838 — SKIN STAT II SKIN STAPLING MEDICAL DEVICE (January 23, 1985)

FDA data resources