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510(k) K931597

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

K931597 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAPACE INCISION AND DRAINAGE TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 5, 1993. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800. Carapace, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION 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)

FDA data resources