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510(k) K925526

MANIPLER DISPOSABLE SKIN STAPLER by Matsutani Seisakusho Co. , Ltd. — Product Code GDT

K925526 is an FDA 510(k) premarket notification submitted by Matsutani Seisakusho Co. , Ltd. for the device "MANIPLER DISPOSABLE SKIN STAPLER". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
November 2, 1992
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 for product code GDT

  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • K943719 — VISISTAT STAPLER (August 24, 1994)
  • 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)
  • K861711 — SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE (May 16, 1986)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)
  • K844838 — SKIN STAT II SKIN STAPLING MEDICAL DEVICE (January 23, 1985)
  • K844837 — VISISTAT SKIN STAPLING DEVICE (January 23, 1985)

FDA data resources