Home / 510(k) Clearances / K963234

510(k) K963234

STAPLE REMOVAL KIT by Continental Medical Laboratories, Inc. — Product Code GDT

K963234 is an FDA 510(k) premarket notification submitted by Continental Medical Laboratories, Inc. for the device "STAPLE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on October 21, 1996. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. Continental Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1996
Date Received
August 19, 1996
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 Continental Medical Laboratories, Inc.

  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963443 — PROD. NO. 02-031 - LACERATION TRAY (October 17, 1996)
  • K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER (October 11, 1996)
  • K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING (September 23, 1996)
  • K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (June 21, 1996)
  • K952335 — WOUND CARE MANAGEMENT KITS (June 14, 1995)
  • K905123 — G-TUBE DRESSING CHANGE TRAY (March 27, 1991)

Other clearances for product code GDT

  • 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)
  • K861711 — SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE (May 16, 1986)
  • 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