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510(k) K943719

VISISTAT STAPLER by Pilling Weck, Inc. — Product Code GDT

K943719 is an FDA 510(k) premarket notification submitted by Pilling Weck, Inc. for the device "VISISTAT STAPLER". The FDA issued a decision of Substantially Equivalent on August 24, 1994. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. Pilling Weck, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1994
Date Received
August 1, 1994
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 Pilling Weck, Inc.

  • K990547 — PILLING WECK SURGICAL Y STENT FORCEPS (April 27, 1999)
  • K974250 — VERSASTAT MULTIPOLAR SCISSORS AND CABLES (February 11, 1998)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K945520 — HEMOCLIP ECOSYSTEM (January 27, 1995)
  • K944552 — PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP (November 7, 1994)

Other clearances for product code GDT

  • K963234 — STAPLE REMOVAL KIT (October 21, 1996)
  • 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)
  • 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