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510(k) K920283

DISPOSABLE SKIN STAPLE REMOVER by Trinity Laboratories, Inc. — Product Code MCZ

K920283 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "DISPOSABLE SKIN STAPLE REMOVER". The FDA issued a decision of Substantially Equivalent on May 22, 1992. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1992
Date Received
January 22, 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 Trinity Laboratories, Inc.

  • K981441 — HEART CATH TRAY, STERILE, DISPOSABLE (July 10, 1998)
  • K974238 — DENTAL TRAY, STERILE, DISPOSABLE (February 4, 1998)
  • K974286 — CIRCUMCISION TRAY, CAT. NO. 70340 (December 12, 1997)
  • K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATIO (August 1, 1997)
  • K970722 — EYE TRAY (March 31, 1997)
  • K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)
  • K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE (January 22, 1997)
  • K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
  • K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
  • K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

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)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)

FDA data resources