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510(k) K922339

SUTURE REMOVAL KIT by Transidyne General Corp. — Product Code MCZ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 11, 1992
Date Received
May 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture Removal Kit
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Transidyne General Corp.

  • K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
  • K955658 — LACERATION TRAY (January 25, 1996)
  • K950773 — PROPHYLAXIS PACK (March 31, 1995)
  • K950743 — ORAL PROCEDURE PACK (March 31, 1995)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)
  • K897133 — MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (March 30, 1990)

Other clearances for product code MCZ

  • K050656 — AMSINO SUTURE REMOVAL KIT (May 2, 2005)
  • K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT (February 14, 1997)
  • K963714 — GRAND MEDICAL SUTURE REMOVAL KIT (November 27, 1996)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K941465 — SUTURE REMOVAL KIT (April 22, 1994)
  • K931597 — CARAPACE INCISION AND DRAINAGE TRAYS (November 5, 1993)
  • K925015 — STERILE SUTURE REMOVAL KIT (June 7, 1993)
  • K924835 — VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 (March 23, 1993)
  • K924834 — PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) (March 23, 1993)
  • K915827 — A.C.S. SUTURE REMOVAL KIT (December 8, 1992)