510(k) K931597

CARAPACE INCISION AND DRAINAGE TRAYS by Carapace, Inc. — Product Code MCZ

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: November 5, 1993
Date Received: April 1, 1993
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 Carapace, Inc.

K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
K931729 — I.V. START KIT (February 22, 1994)
K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

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)
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)
K922339 — SUTURE REMOVAL KIT (December 11, 1992)
K915827 — A.C.S. SUTURE REMOVAL KIT (December 8, 1992)